Generitech Corporation

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

You failed to investigate out-of-specification (OOS) assay results for several lots of your topical over-the-counter (OTC) drug products. For example, assay testing for salicylic acid in your **(b)(4)** drug product Lot **(b)(4)** revealed results including 1.93% and 1.90% (retest). Your specification for this critical product attribute was **(b)(4)**% - **(b)(4)**%.

Passage 3

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. 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 (2)).

Passage 4

You failed to perform an identity test for each component lot used in the production of your drug products, including for the salicylic acid active pharmaceutical ingredient in your **(b)(4)** drug product Lot **(b)(4)**. Further, you did not establish the reliability of each of your suppliers’ certificates of analyses (COA) for component specifications and characteristics.

Passage 5

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 (21 CFR 211.100(a)).

Passage 6

Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).

Passage 7

You failed to demonstrate that your cleaning and disinfection practices are adequate to remove contaminants from the shared equipment used to manufacture both topical OTC

Passage 8

Failure to address violations may also cause the FDA to withhold issuance of Export Certificates. The 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.