Active Cosmetics Manufacturing Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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).

Passage 2

Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).

Passage 3

You failed to adequately validate your alternative rapid microbiological test methods. You use the Neogen Soleris Next Generation System for rapid microbiological testing of your finished drug products (e.g., total aerobic counts, total counts, specified microorganisms) and failed to demonstrate that it was equivalent to or better than United States Pharmacopeia (USP) compendial methods and suitable for its intended use.

Passage 4

Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Passage 5

You failed to perform adequate identity testing on each shipment of each lot of incoming components (e.g., **(b)(4)**) used in the manufacture of your drug products. In addition, you relied on your suppliers’ certificate of analysis (COA) without establishing the reliability of each of your component suppliers’ analyses at appropriate intervals.

Passage 6

Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.