Inspections, Compliance, Enforcement, and Criminal Investigations
Pharmaceutical Laboratories and Consultants, Inc. 25-Jul-07
Department of Health and Human Services
Public Health Service
July 25, 2007
RETURN RECEIPT REQUESTED
James R. Stephen, President
Pharmaceutical Laboratories and Consultants, Inc.
200 Howard Ave., Suite 250
Des Plaines, IL 60018
Dear Mr. Stephen:
During an inspection of your contract testing laboratory conducted April 16, 2007 through May 3, 2007, the FDA documented significant deviations from the current Good Manufacturing Practice (cGMP) regulations [Title 21, Code of Federal Regulations (CFR), Parts 210 and 211]. Such deviations cause the prescription and over-the-counter drug products that are tested by your firm to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 351(a)(2)(B)] as follows:
1) There is a failure to establish laboratory controls that include a determination of conformance to scientifically sound and appropriate specifications, standards and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity [21 CFR 211.160(b)]. For example:
• During the establishment inspection, FDA observed that your had incorrectly calculated assay test results for approximately 12 batches of "[redacted]." When the results were re-calculated with the required conversion factor (converting % [redacted] to % [redacted]), approximately 6 of the 12 batches were out-of-specification. At the end of the establishment inspection, your firm had yet to inform the product distributor [redacted] of these material findings.
• Your firm failed to follow the microbial limits testing procedure specified in USP<61> in that your testing procedure analyzes a single sample aliquot preparation when USP<61> specifies analyzing duplicate aliquots of sample preparation.
• Your firm failed to verify the suitability of your chromatographic system used in the assay testing of Menthol for several "[redacted]" products.
2) There is a failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods [21 CFR 211.165(e)]. For example:
• Your firm failed to validate your four most frequently performed analytical test methods used to assay the drug products' active ingredients. For example, your firm did not validate the following assays:
-Assay of [redacted] for [redacted] (using HPLC);
-Assay of [redacted] Treatment for Benzalkonium Chloride (using titration);
-Assay of [redacted] products for various active ingredients, including Menthol and Camphor (using GC);
-Assay of [redacted] for [redacted] (using HPLC).
3) There is a failure of laboratory records to include a complete record of all data obtained during testing [21 CFR 211.194(a)(4)]. For example:
• Your firm failed to record the raw data for the preparation and testing of growth media used in the microbiological testing of drug products.
Additionally, drug products analyzed by your firm are misbranded within the meaning of Section 502(o) of the Act in that they were tested and controlled in an establishment that failed to reregister as required under 21 CFR Part 207.22(a). This regulation requires firms to make subsequent annual registrations after the initial registration. Based on the FDA's Drug Registration and Listing Database, your firm registered with FDA in February of 2003 under Pharmaceutical Analytical Laboratories (registration number 3003982646) and has failed to submit required annual registrations since 2003.
The violations identified above are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure adherence with each requirement of the cGMP regulations and the Federal Food, Drug, and Cosmetic Act. For regulatory and scientific guidance, please refer to the FDA's website, at http://www.fda.gov/cder/guidance/index.htm.
Federal Agencies are advised of the issuance of all Warning Letters about drugs so that they may take this information into account when considering the award of contracts.
You should take prompt action to correct these violations. Failure to promptly correct these deviations may result in regulatory action by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
You should notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct these violations, including a detailed explanation of each step taken to ensure that these types of violations do not reoccur. If corrective action has not been completed, please provide a timetable within which the corrections will be completed.
Your response should be directed to the attention of Compliance Officer George F. Bailey at the address listed above. If you have any questions regarding any issue in this letter, please contact Mr. Bailey at (312) 353-5863.
Scott J. Maclntire