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BENJAMINS JAMAICA’S FDA WARNING LETTER

P.A. Benjamin Manufacturing Co., Ltd. 1/29/13

Department of Health and Human Services
Public Health Service
Food and Drug Administration
Silver Spring, MD 20993

images
Warning Letter

CERTIFIED MAIL WL: 320-13-07
RETURN RECEIPT REQUESTED

January 29, 2013

Mr. Errol L.G. Powell
Chairman
P.A. Benjamin Manufacturing Co., Ltd.
95-97 East Street
Kingston, Jamaica

Dear Mr. Powell:

During our May 5 through 11, 2012, inspection of your pharmaceutical manufacturing facility, P.A. Benjamin Manufacturing Co., Ltd., located at 95-97 East Street, Kingston, Jamaica, investigator(s) from the U.S. Food and Drug Administration (FDA) identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug product(s) to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 351(a)(2)(B), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.

We have conducted a detailed review of your firm’s response of May 24, 2012, and note that it lacks sufficient corrective actions.

Our investigator(s) observed specific violations during the inspection, including, but not limited to, the following:

CGMP VIOLATIONS
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Two examples of this violation include:

Lot #JU83 of Infant Gripe Mix failed the pH specification. The range was (b)(4) to (b)(4), whereas the result recorded in the batch record was (b)(4).
Lot # KM40 of Diphenhydramine Expectorant failed specific gravity and (b)(4). The results for specific gravity and (b)(4) were (b)(4) and (b)(4), whereas the acceptable ranges were (b)(4)-(b)(4) and (b)(4)-(b)(4), respectively.

You conducted no investigation for these failures, yet you released these lots for distribution. The quality assurance manager stated that the specification failures did not impact the therapeutic activity of the drug products but provided no evidence to support this conclusion. In your response to this letter, provide your investigation into these failures and the action plan regarding failed batches that are within expiry and currently in U.S. distribution.

In addition, please provide a detailed description of the changes and improvements made to your investigation procedures.

Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products (21 CFR 211.22(a)).

Two examples of this violation include:

a. The quality unit (QU) failed to review or approve drug product production batch records before release and distribution of your products. For example, your firm released for distribution lot #JM11 of Infant Gripe Mixture and lot #JS17 of Benjamins Cough and Cold, notwithstanding the fact that your QU did not provide review of multiple corrections of documentation errors.

b. Your quality unit failed to review and approve multiple changes your firm made to the manufacturing processes. For example, during the manufacture of lot # KM 40 of Diphenhydramine Expectorant, your firm added (b)(4) to the bulk tank. This step was not in the master batch record and your QU did not review or approve these changes.

In your response to this letter, please include a detailed plan on how your quality unit will provide consistent, adequate review and approval of investigations and production batch records. Include a list of all responsibilities assigned to the quality unit.

Your firm failed to conduct at least one specific identity test on a component when relying on that component supplier’s analysis (21 CFR 211.84(d)(2)).

For example, your firm released raw materials, including glycerin, (b)(4), (b)(4), and (b)(4), relying only on the certificates of analysis. The performance of identity testing on each incoming ingredient lot is a fundamental part of good manufacturing practice. An incoming lot cannot be accepted based on the identification test result listed on a vendor’s certificate of analysis. In particular, glycerin and (b)(4) are vulnerable to intentional adulteration and incoming lots should be afforded special quality control scrutiny prior to a lot disposition decision for use in manufacturing. For more guidance, see Testing for Glycerin for Diethylene Glycol (May, 2007) at http://www.fda.gov/downloads/Drugs/…/Guidances/ucm070347.pdf.

In your response to this letter, describe in detail your raw material testing program, including how you will ensure that raw materials used in the manufacture of your drug products will be withheld from use unless the lot has been tested or examined in accordance with the current USP/NF and released for use by the quality control unit. In addition, describe your vendor qualification program and your procedures to periodically verify each vendor’s full certificate of analyses.

Your firm failed to establish and follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile (21 CFR 211.113(a)).

For example, your firm lacks written approved procedures to prevent microbial contamination during the manufacturing operations of over-the-counter (OTC) drug products at your facility. Additionally, there was no evidence that your firm tested finished drug products for microbial limits. For example, your firm did not perform total aerobic microbial count (TAMC) and total combined yeast and mold counts (TYMC) to ensure a low bioburden.

In your response to the inspectional observations, you acknowledged a need to develop validated and approved procedures to prevent microbial contamination during manufacturing. However, you did not describe these procedures, nor did you describe your plans for testing microbial quality of raw materials, in-process intermediates, and finished products.

We are concerned about your firm’s failure to assure appropriate microbial quality of the drug products shipped to the U.S. market. For example, some of your products are to be given orally to infants and they have not been tested for microbial contamination. Provide a risk assessment of all the drug products that remain within expiration in U.S. distribution, as well as an action plan to ensure that the products released for distribution are free of objectionable contamination.

Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).

For example, your firm failed to validate a cleaning method used for the multi-product manufacturing equipment and utensils. Your firm has no assurance that your current, manual cleaning methods are effective in removing residues of drug products and detergents from the manufacturing equipment and utensils. Additionally, your firm failed to validate the “(b)(4)” device used to detect (b)(4) traces on the equipment surfaces after cleaning. Finally, your firm failed to implement procedures on the proper use of the device.

In your response, you acknowledged your failure to implement and record the validation of your firm’s cleaning processes. Your response is inadequate because it did not include a plan to implement cleaning procedures to ensure that drug product residues and cleaning agents are removed adequately. In your response to this letter, please provide your updated cleaning procedures, protocols for demonstrating that these procedures are effective, and reasonable timelines for executing these protocols. If you choose to continue manufacturing prior to completion of the cleaning validation, submit the acceptance criteria you will use for cleaning verification. You should also include your evaluation of the potential for cross-contamination of products currently in distribution in U.S. due to inadequate cleaning. During our next inspection, we will confirm proper qualification of equipment as well as suitability of test methods.

Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).

Specifically, your firm has not validated the manufacturing processes for the OTC drug products, Diphenhydramine Elixir, Diphenhydramine Expectorant, and Infant Gripe Mix. In addition, you reprocessed several batches of these products without approval by the Quality Unit and without assessing the impact of the changes on the quality of the product.

In your response, you should include validation plans for the production and process control procedures you use in the manufacture of drug products intended for U.S. distribution. Additionally, include a revised master batch record and procedure for reprocessing batches after quality unit approval.

Validated processes help ensure that your products are manufactured reproducibly, master batch records are adequate, and variability is controlled to prevent batch failures. Additionally, monitoring of process performance and product quality throughout the process validation lifecycle provides opportunities to improve control of your manufacturing processes and the quality of your products.

The items listed above, as well as other deficiencies found by our investigator, lead us to question the effectiveness of your current quality system to achieve overall compliance with CGMP at your facility. It is essential that your firm implement a robust quality system. We remind you that you are responsible for ensuring that your firm’s drug manufacturing operations comply with applicable requirements, including the CGMP regulations. FDA strongly recommends that your firm’s executive management immediately undertake a comprehensive and global assessment of your manufacturing operations to ensure that your systems and processes, and ultimately, the drug products you manufacture, conform to FDA requirements. We also recommend that you hire a qualified consultant to provide your firm’s staff with CGMP guidance and training on GMPs and particularly the responsibilities and procedures applicable to the quality unit.

UNAPPROVED NEW DRUG AND MISBRANDING VIOLATIONS

In addition to violating CGMPs, Benjamins Flu Relief, Benjamins Diphenydramine Expectorant, Benjamins Diphenydramine Elixir, Benjamins Sinus, Benjamins Cold and Cough and Benjamins Infants Gripe Mixture are OTC products that violate the unapproved new drug and misbranding provisions of the Act. As described in more detail below, these products are unapproved “new drugs” in violation of section 505(a) of the Act [21 U.S.C. § 355(a)]. In addition , Benjamins Flu Relief, Benjamins Diphenydramine Expectorant, Benjamins Diphenydramine Elixir, Benjamins Sinus, and Benjamins Cold and Cough are also all misbranded under 502(f)(2) the Act [21 U.S.C. § 352 (f)(2)] and Benjamins Flu Relief is further misbranded under Section 502(c) of the Act [21 U.S.C: § 352(c)].

According to the labeling for Benjamins Flu Relief, Benjamins Diphenydramine Expectorant, Benjamins Diphenydramine Elixir, Benjamins Sinus, and Benjamins Cold and Cough these products are drugs within the meaning of Section 201(g)(1)(B) of the Act, 21 U.S.C. § 321(g)(1)(B), because they are intended for use in the diagnosis, treatment, or prevention of disease, and under section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)] because they are intended to affect the structure or function of the body.

Furthermore, the products are intended for purposes that include as an antihistamine, expectorant, antitussive and/or decongestant and include uses for addressing cough cold symptoms. In order for OTC antihistamine, expectorant, antitussive, decongestant or other related cough cold products to be generally recognized as safe and effective and not misbranded, and thus be marketed without an approved NDA, they must meet the requirements of the final monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for OTC use, 21 CFR Part 341. Benjamins Flu Relief, Benjamins Diphenydramine Expectorant, Benjamins Diphenydramine Elixir, Benjamins Sinus, and Benjamins Cold and Cough are unapproved new drugs because they do not meet this final monograph and are not otherwise covered by an FDA-approved application.

Among the violations for these products, the labeled directions for use for these products do not comply with the directions for use set forth under the final monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for OTC use, 21 CFR Part 341. For example, Benjamins Flu Relief, Benjamins Sinus, and Benjamins Cough and Cold contain dosing directions for children down to one year of age when the final monograph provides that one should consult a doctor for children under two. Furthermore, Benjamins Diphenhydramine Expectorant contains dosing directions for children down to the age of three and Benjamins Diphenhydramine Elixir contains dosing directions down to the age of two years when the final monograph provides that one should consult a doctor for children under six years of age for antihistamine containing drug products.

In addition, Benjamins Diphenhydramine Expectorant and Benjamins Cough and Cold contain active ingredients that do not comply with the final monograph, such as (b)(4) and (b)(4). Furthermore, Benjamins Flu Relief and Benjamins Cough and Cold contain indications that do not comply with the final monograph, such as (b)(4) and (b)(4), respectively.

Thus, as formulated and labeled, Benjamins Flu Relief, Benjamins Diphenydramine Expectorant, Benjamins Diphenydramine Elixir, Benjamins Sinus, and Benjamins Cold and Cough are not generally recognized as safe and effective for the indications described in their labeling, and therefore, are new drugs under section 201(p) of the Act [21 U.S.C. § 321 (p)]. Under section 505(a) of the Act [21 U.S.C. § 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an FDA-approved application. Your firm’s marketing of Benjamins Flu Relief, Benjamins Diphenydramine Expectorant, Benjamins Diphenydramine Elixir, Benjamins Sinus, and Benjamins Cold and Cough without FDA-approved applications violates this provision of the Act.

The products Benjamins Flu Relief, Benjamins Diphenydramine Expectorant, Benjamins Diphenydramine Elixir, Benjamins Sinus, and Benjamins Cold and Cough are also all misbranded under 502(f)(2) the Act because the products’ labeling fails to bear all of the required warnings described in the final monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for OTC use, 21 CFR Part 341 for each declared active ingredient. Benjamins Flu Relief and Benjamins Sinus are also misbranded under section 502(f)(2) of the Federal Food, Drug and Cosmetic Act (the Act) because the products’ labeling does not comply with FDA’s organ specific labeling regulation for acetaminophen containing OTC drug products. Specifically, they do not include the required liver warning information described 21 C.F.R. § 201.326(a)(1)(iv). Please note that this warning is required to be on both outer and immediate container labeling if there is both an outer and immediate container.

Benjamins Flu Relief is also not labeled in accordance with the “Drug Facts” labeling requirements described in 21 C.F.R. § 201.66. Therefore, this product is further misbranded under section 502(c) of the Act [21 U.S.C. § 352(c)], because the information that is required to appear on the labeling is not prominently placed thereon with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the Act [21 U.S.C. § 331(a)]. Therefore, the marketing of Benjamins Flu Relief, Benjamins Diphenydramine Expectorant, Benjamins Diphenydramine Elixir, Benjamins Sinus, and Benjamins Cold and Cough violates this provision of the Act.

Furthermore, the product Benjamins Infants Gripe Mixture as formulated and labeled is an OTC drug. The product contains a combination of active ingredients and indications that are not covered under FDA’s OTC Drug Review, which establishes conditions for general recognition of safety and effectiveness for OTC drugs. Furthermore, we are not aware of a product with your formulation and labeling otherwise being eligible for the OTC Drug Review nor are we aware of any evidence establishing that a product as formulated and labeled as Benjamins Infants Gripe Mixture is generally recognized as safe and effective for the described indications. Therefore, Benjamins Infants Gripe Mixture is a new drug under section 201(p) of the Act [21 U.S.C. § 321 (p)]. Under section 505(a) of the Act [21 U.S.C. § 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an FDA-approved application.

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations.

Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer. In addition, your failure to correct these violations may result in FDA continuing to refuse admission of articles manufactured at Benjamin Manufacturing Co., Ltd., located at 95-97 East Street, Kingston, Jamaica, into the United States. The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the Act, 21 U.S.C. 381(a)(3), in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of Section 501(a)(2)(B) of the Act, 21 U.S.C. 351(a)(2)(B).

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct and prevent the recurrence of violations, and provide copies of supporting documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the date by which you will have completed the corrections. Additionally, if you no longer manufacture or distribute the drug product(s) at issue, provide the date(s) and reason(s) you ceased production. Please identify your response with FEI # 3004341688.

Please send your reply to:

Allison A. Aldridge, Ph.D.
Compliance Officer
U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Office of Manufacturing and Product Quality
Division of International Drug Quality
White Oak, Building 51, Room 2258
10903 New Hampshire Ave
Silver Spring, MD 20993
Tel: (301) 796-0483
Fax: (301) 847-8741

40 Responses to BENJAMINS JAMAICA’S FDA WARNING LETTER

  • ISpy (With my two big black eyes) says:

    Mi seh Met..ah boy yuh think that man is someone nice him fired one man weh wuk there for over 34 yrs and didnt want to pay till the man affi go Ministry a Labour go file claims a so him actually get him money ….mi sey some a dem ppl yah not nice dem and dem family alone wah live big

  • Met says:

    but ispy u mean to tell mi dem really nah clean di place and a sell contaminated tings?

  • Sasha fierce says:

    Dear Lord nothing no pass . Incorrect labeling , wrong dosage . Labeling for children under 2 yrs . Bacteria , yeast and all kinds of things mix up . Equipment not clean properly . Dem a try kill off people ..

  • Cindy Royal says:

    But unuh notice one a di main products di FDA speak to is a product made FOR BABIES? And the other is a cold medicine that many many adults & children ingest. An up to yesterday mi stop into a supermarket an still si dem prominently displayed on the shelves. Di supermarkets fi ban Benjamin til dem sort out dem manufacturing processes.

  • Met says:

    cindy dem fi ban dem island wide because this really bad

  • ISpy (With my two big black eyes) says:

    Ah boy Ms. Met a so it go when yuh wanna have have have fi live big and dont wanna spend back pon yuh business…driving 2012 land rover and dont wanna spend pon di workers or the place…a reaction a tek him…wow tek over place and dont want to pay the man.

  • Cindy Royal says:

    Yes Metty, an fling di book at dem cuz improper manufacturing can harm ppl. Our authorities are too damn slack! Wi have every rule & regulation inna di world fi address every kinda breech but fi some strange reason wi naw enforce dem.

  • my2cents says:

    Met, thank u so much for this post because I usually buy things like glycerin and eucalyptus oil and whatever in that brand. I also have friends and family with children and I am sure they buy medication in that brand for their kids.

  • noontime says:

    so what were the Jamaican authorities doing all this time? Why is the FDA haffi come in and expose dem? Bwoy u can get away wid anything ah Jamaica, nobody to account to. Greed ah guh kill we

  • ISpy (With my two big black eyes) says:

    noontime that mi a sey too..dem a talk sey we fi support Jamaican products and bblah blah blah but honestly where are the health inspectors that should be doing all this ensuring that the place is santized !!!!!!!! how much ppl gooda all get sick from them tainted products dey and dont even know sey a that cause it..kmft Authorities dem a one big f—ng joke

  • Met says:

    2cents thank cindy because mi jus sign up wid di fda and dem tings last month so now all these things wont miss me or di wall

  • ISpy (With my two big black eyes) says:

    lawg God a tru 2cent cah most mothers a jamaica love buy the Glycerin to wipe them baby tongue.

  • Jules says:

    Mawning mi ppl.

    Mi haffi tell mi madda dis. Nutten mi lub like mi essence a peppomint, den all dat inna di mixup. A money dem nuh hab fi upkeep or dem juss duncyah?

  • ISpy (With my two big black eyes) says:

    @ jules duncyah..di place a mek money but the man nuh like spend on others cah him affi keep up wid the Jones..oh

  • my2cents says:

    Well thanks Cindy :2thumbup . Met me jus link couple people and tell dem not to use or buy anymore Benjamin’s products.

  • Met says:

    2cents I only buy dem vanilla but now mi only use it once in a while ..the real extract not so expensive anymore

  • Anonymous says:

    Inspections, Compliance, Enforcement, and Criminal Investigations

    P.A. Benjamin Manufacturing Co., Ltd. 1/29/13

    Warning Letter

    http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm338048.htm

  • ISpy (With my two big black eyes) says:

    Ms. Met a bet yuh mi last dime sey some media house ago run with the story now..after JMG did the work!!!!!!

  • Met says:

    ispy a dat mi seh to miself..u a go si in a few hours what happen

  • ISpy (With my two big black eyes) says:

    but then a again money talks somebody a bureau a standard nah do them wuk ohhhh that is all me know

  • my2cents says:

    metty off topic, den chino still a sing fi yendi? Me think dem feel secure by now

    https://www.youtube.com/watch?feature=player_embedded&v=JuBfIYNppzs#!

  • Met says:

    2cents dis one nuh sound bad oooooooooo but a wonder who did a set fi call press :nerd

  • Cindy Royal says:

    Bureau of Standard seh is not dem deal wid dat, dem seh is Ministry of Health – I’m guessing the public health department.

  • Riches says:

    Met, thanks so much for this article, my company insures P.A> Benjamin wow! passing on the info this is critical!

  • Met says:

    cindy people haffi complain to the bureau first nuh so?

  • Met says:

    Riches :hammer
    dem fi get it a lot of Jamaicans swear by benjamins eno

  • ISpy (With my two big black eyes) says:

    How Bureau fi say a nuh dem…and dem same one di involve inna La. Fraud lewis shutting down, I would think BSU/I is responsible fi this all me know this was keep under the carpet long

  • Riches says:

    i just sent the info to the relevant persons, we have liability coverage for them suh dis is some serus ish, i myself use P.A. products an as u rightly seh most jamaicans swear by P.A. oh bwoy

  • Met says:

    cindy :thumbup fi di homework

  • Cindy Royal says:

    Yuh seet Ispy! A di same ting mi did a seh, dem cudda run eenn pan LA but dem a gwan like PA Benjamin untouchable. A wah a choo LA nave no money or sumting? kmt.

    But yuh know di runnings man, 1 agency who have responsibility a shirk dem duties by saying anuh dem a smaddy else, den dat smaddy else seh anuh dem a smaddy else an it galang suh til if frustrate di media til dem jus give up an it die a natural death an we (di Jamaica ppl) continue suffa. kmt

  • my2cents says:

    and how you nuh give we this bit of news about Mr. Exotic??

    http://www.examiner.com/article/ninja-man-recovering-hospital-following-car-crash

  • Met says:

    that happen friday oo mi shudda fix it up for sunday ..ninja ok dem mussy se something ina him kidney mek him nuh come out

  • ISpy (With my two big black eyes) says:

    Cindy from this piece a info it’s clear that them nah produce the goods up to standard and dem look like dem all a dilute and a use substitute stuff dem a use over there..awh boi ..Met a wonder if yuh know the history of P.A benjamin that it was owned by the Matalon’s and this man used to work with them and buy it out now him go drop the ball..but a feel a God a beat him

  • Met says:

    ispy I didnt know that!

  • ISpy (With my two big black eyes) says:

    Yes Met and so was Serge Island..Butterkist..Facey and whole heap more but them sell out what fi sell out and keep wah fi keep and dis man come a tarnish the good up good up name a di brand

  • Cindy Royal says:

    There is issues of cleanliness too Ispy & them not doing necessary testing on their products, but yet still, without any kind of proof, their quality assurance manager is going to try & convince FDA that the products r good. Up to yesterday when he spoke to Nationwide he did not deny any of the findings of the FDA, but claimed Jamaicans need not worry. How can we not worry when they are not carry on a clean operation? kmt

  • Met says:

    so dem jus go round and buy out di place dem and mash dem up?

  • Cindy Royal says:

    There *are*

  • Cindy Royal says:

    Some a dem too damn busy being Mr. Boss Man, Mr. Managing Director or Mr. Executive Chairman fi run dem business properly Met. Dem deh pan such a hype being boss, bitching out dem workers & flossing in public dat dem business is always in mess.

  • Jules says:

    Tenks fiddi clairifaction Ispy.

    Dem betta come correct cawsen like how barely anyting a produce a yawd again, dis juss gi certain places ideas fi roll een pon di likkle manufacturing sector. Dis piss mi off cause Jamaica always produce products of high quality and wi known fi dat, and dis juss a mash up wi reputation. Kmt

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