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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ameriderm Laboratories, Ltd. 12/2/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 New Jersey District Office
Central Region
Waterview Corporate Center
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054
Telephone: (973) 331-4900
FAX: (973) 331-4969  
 

WARNING LETTER

December 2, 2013
 

UNITED PARCEL SERVICE

Mr. Bernard Elefant
President
Ameriderm Laboratories, Ltd.
126 Pennsylvania Ave.
Paterson, NJ 07503-2505

14-NWJ-02
 

Dear Mr. Elefant:

During our inspection ending on February 13, 2013, of your pharmaceutical manufacturing facility, Ameriderm Laboratories, Ltd., located at 126 Pennsylvania Avenue, Paterson, NJ 07503, investigators 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 products 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 and note that it lacks sufficient corrective actions.

Our investigators observed specific violations during the inspection, including, but not limited to, the following:

1.    Your firm failed to withhold each lot of components, drug product containers and closures from use until the lot has been sampled, tested or examined as appropriate and released for use by the quality control unit (21 C.F.R 211.84(d)(2)).

For example, you have not tested the water used in the manufacture of your Over-the-Counter (OTC) drug products to ensure the absence of objectionable microorganisms since 2006. Several microorganisms including Pseudomonas aeruginosa, Cronobacter sakazakii, Burkholderia pseudomallei and Acinetobacter ursingii were isolated and identified from the water samples that our investigators collected during the inspection.

In your response you state your firm will increase water sampling to (b)(4) times per year and explore the use of specialized media. Your response is inadequate because your firm uses deionized water to manufacture drug products intended for human use. Water utilized in the production of finished human drug products must, at a minimum, meet the Purified Water, USP, monograph as well as appropriate limits for microbial count. In addition, your firm continues to fail to monitor water quality routinely as you only commit to collecting (b)(4) samples per year. Your response also does not include an investigation into the root cause of the unsatisfactory microbial control of your water system.

To facilitate compliance with CGMPs, please refer to FDA's guidance on water system design, control, and monitoring entitled Guide to Inspections of High Purity Water Systems for more information.

It is essential that your firm's topical products be produced in a manner that is appropriate in View of their intended uses. We note that some of your firm's products are used in either a hospital or nursing home setting, or applied on broken skin. It is critical that your firm considers the intended uses of your products when determining manufacturing and testing standards. These products should be consistently manufactured to minimize bioburden and be free of objectionable microorganisms.

This is a repeat observation from the June 2011 inspection.

2.    Your firm failed to have an adequate laboratory facility available for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products (21 CFR 211.22(b)).

For example, assay methods used by your contract testing laboratory to test your finished products (e.g. Instaclean and PeriShield) for release have not been validated.

Your response is inadequate because you failed to address this deficiency.

3.    Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

For example, your firm failed to establish finished product specifications for AmeriWash, DermaFix, Instaclean, and PeriShield.

In your response, you state you will now include recently developed Product Specification Sheets in your batch record and for the final disposition process. This response is not adequate because it does not sufficiently address the deficiency. Your firm failed to provide a scientific rationale or data to support your finished product specifications.

This is a repeat observation from the June 2011 inspection.

4.    Your firm failed to establish 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 (21 CFR 211.100(a)).

For example, you have not validated the manufacturing processes for AmeriWash, DermaFix, Instaclean, and PeriShield. Your firm has not identified the component attributes (e.g., solubility and viscosity) and the process parameters (e.g., mixing time, blending speed, and temperature) that are important to produce these four OTC drug products (i.e., topical gels, creams, and ointments) with consistent quality. Your firm does not have assurance that the manufacturing processes are adequately controlled to consistently ensure the quality and safety of AmeriWash, DermaFix, Instaclean, and PeriShield.

In addition, your firm's batch records do not document all significant process steps and parameters such as mixing times, blending speeds, bulk hold times, and product yields. It is imperative that you have adequate records to monitor and demonstrate control of your processes and ensure that specified requirements are reproducibly (as determined during initial process validation studies, and thereafter) achieved.

In your response, you state that you are in the process of designing validation studies that were to be completed on August 15, 2013, for AmeriWash, DermaFix, Instaclean and PeriShield. Your response is inadequate because your firm failed to submit any information (e.g., improved batch records, validation reports) describing the outcomes of your validation activities.

This is a repeat observation from the June 2011 inspection.

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

For example, the cleaning procedures described in Chapter 2-SOP-5 Cleaning of Batching Vessels lack detailed instructions for the cleaning and sanitization of non-dedicated equipment, including mixing kettles and tanks, used to manufacture your OTC drug products. There is no assurance that the cleaning and sanitization methods described in your cleaning validation documents are adequate.

In addition, your firm does not maintain individual equipment logs for non-dedicated equipment, including mixing kettles and tanks, in order to document equipment cleaning, maintenance, and use.

Your response is inadequate because the revised procedure you provided lacks sufficient details including cleaning agent concentrations, equipment disassembly instructions, cleaning frequency, rinse times and water temperatures. You have also failed to provide any information describing how the cleaning process will be documented and monitored, or your method for determining cleaning effectiveness.

This is a repeat observation from the June 2011 inspection.

6.    Your firm failed to record and justify deviations from written production and process control procedures (21 CFR 211.100(b)).

For example, Chapter 1-SOP-2 titled Deviating from Standard Operating Procedures lacks details about when and how deviations from SOPs "in the event of extenuating circumstances" will be investigated.

The procedure in your response indicates that deviations will now be investigated to address a root cause and include any appropriate corrective actions. Your response is inadequate because it fails to define the oversight role of the Quality Unit in the investigative process or mention how your new process will be documented or monitored. Your response also lacks a timeframe for the implementation of your revised procedures and fails to discuss employee training.

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.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. Other federal agencies may take this warning letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending drug applications listing your facility, until the above violations are corrected. FDA may re-inspect to verify corrective actions have been completed.

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 products at issue, provide the date(s) and reason(s) you ceased production. Please identify your response with FEI 3001452902.

Please send your reply to the following address: U.S. Food and Drug Administration 10 Waterview Blvd, 3th Floor Parsippany, NJ 07054, Attn: Stephanie Durso, Compliance Officer.
 

Sincerely,
/S/
Diana Amador-Toro
District Director
New Jersey District