Cosmobeauti Laboratories & 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 conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable organisms. Your firm also failed to test an adequate number of batches of each drug product to determine an appropriate expiration date. (21 CFR 211.165(b) and 21 CFR 211.166(b)).

Passage 2

You failed to perform microbiological testing on each batch of your finished drug products. In addition, you lacked sufficient stability data to support the assigned shelf-life for your OTC drug products.

Passage 3

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. Your firm also failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.100(a) and 21 CFR 211.188).

Passage 4

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.