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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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American Analytical Chemistry Laboratories, Ltd. 06-Feb-03

Department of Health and Human Services' logo

Public Health Service
Food and Drug Administration

  Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5663


February 6, 2003

WARNING LETTER
CHI-8-03
CERTIFIED MAIL
RETURN RECEIPT REOUESTED

Zhenchang Charlie Li, Ph.D., President
American Analytical Chemistry Laboratories Corp., Inc.
101 Tomaras Avenue
Savoy, IL 61874

Dear Dr. Li:

During an inspection of your contract testing laboratory, conducted from October 17-25, 2002, FDA Investigators documented deviations from the Current Good Manufacturing Practices (cGMPs) for Finished Pharmaceuticals (Title 21, Code of Federal Regulations (CFR), Part 211). These violations cause all drug products tested at your facility to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. The violations from 21 CFR 211 include:

Failure to establish and follow laboratory controls, which are based on sound scientific specifications, standards and test procedures. Your firm has no standard operating procedures (SOP) that describes how test results are to be calculated and
reported. For example, for samples 026-107, 026-108 and 026-109 of the product Dextromethorphan 10mg/5ml and Guaifenesin 100mg/5ml syrup, the assay result reported for Dextromethorphan Hydrobromide was based on the last sample
injection only, while the assay result reported for Guaifenesin was calculated as the average of the [redacted] sample injections. In addition, deviations from test procedures are not recorded and justified. For example, the current inspection revealed that [redacted] of [redacted] HPLC USP test methods used by your firm, which were reviewed by the investigators, had been modified and there was no data that demonstrated the test methods were verified under actual conditions of use [21 CFR 211.160(a)].
Laboratory records do not include complete records of any testing and standardization of laboratory reference standards. For example, laboratory records reviewed during the inspection failed to include information identifying the standards used in the analysis and the method of preparation for those standards [21 CFR 211.194(c)].

Laboratory records are deficient in that they do not include the initials or signature of the second person showing that the original records have been reviewed for accuracy, completeness and compliance with applicable standards [21 CFR 211.194(a)(8)]. For example, the following errors and discrepancies in test records were observed by the investigators:

· The results reported on 6/20/02 and 7/l l/02, for sample 024-562, identified as Chlorhexidine Gluconate Oral Rinse, did not include the molecular weights for the standard and the active ingredient as part of the final calculation.

· The result reported for sample 024-843, identified as tablets containing Acetaminophen, Chlorpheniramine Maleate and Pseudophedrine, used the theoretical standard concentration values in the final calculations. The actual standard concentration values were not determined.

· The Guaifenesin result reported for sample 026-108, identified as 10mg/5ml and Guaifenesin 100mg/ml Syrup, This result reportedly was based on the average of [redacted] injections. The correct average of the [redacted] injections was [redacted]

Written records of investigations into unexplained discrepancies are not made [21 CFR 211.192]. For example:

Sample 024-562, identified as Chlorhexidme Gluconate Oral Rinse, was originally run on 6/20/02 and results were reported on 6/22/02. The initial results reported were subsequently rejected and the sample was re-analyzed for Chlorhexidine Gluconate content on 7/l l/02. There is no documented quality assurance/quality control review of the rejected data.

Your analyst rejected the first two injections of samples 026-107,026- 108 and 026-109 during the assay of Dextromethorphan Hydrobromide due to [redacted]. There was no documented quality assurance/quality control review of the rejected data.

The Guaifenesin result reported for sample 026- 108, identified as Dextrometho han l0mg/5ml and Guaifenesin 100mg/5ml Syrup, wash This exceeded the USP specification for the product. There was no documented quality assurance/quality control review of this incident.

The above identification of violations and the Form FDA 483, List of Inspectional Observations, issued and discussed with you at the conclusion of the inspection is 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. Federal agencies are advised of the issuance of all Warning Letters about drugs and devices so that they may take this information into account when considering the award of contracts.
We acknowledge receipt of your response dated November 20, 2002, to the Form FDA 483 issued at the close of the inspection. The promised corrective actions appear to adequately address the deviations observed and maybe referenced in your response to this letter. In your letter you stated that due to your lack of experience in the pharmaceutical industry, your firm was not aware of the FDA's requirements for the testing of pharmaceutical products. Although your firm is a contract testing laboratory and not a
pharmaceutical manufacturer, Section 21 CFR 210.3(b)( 12) defines testing as part of the drug product manufacturing, processing, packaging and holding process. Therefore, your firm is subject to cGMP requirements pertaining to product testing.

Please submit in writing, within 15 working days of receipt of this letter, your responses to the violations identified in this letter and a detailed report describing the status all corrective actions outlined in your November 20, 2002 letter. Failure to correct the
deviations noted may result in regulatory action without further notice. Your response should be sent to the attention of George F. Bailey, Compliance Officer at the above address.

Sincerely,
/s/
Arlyn H. Baumgarten
District Director