Purolea Cosmetics Lab

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 microorganisms (21 CFR 211.165(b)

Passage 2

Your firm failed to conduct testing for **(b)(4)** for non-sterile **(b)(4)** drug products prior to release and at appropriate intervals for stability. See FDA’s guidance document, *Microbiological Quality Considerations in Non-sterile Drug Manufacturing*, for help minimizing the risks of harmful microbiological contamination of **(b)(4)** drugs at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/microbiological-quality-considerations-non-sterile-drug-manufacturing.

Passage 3

You failed to perform adequate testing for purity, strength, quality, and identity for the components used in the manufacture of your **(b)(4)** drug products. In addition, you relied on your suppliers’ certificates of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.

Passage 4

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.