Clean Cosmetics LLC

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 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 2

Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).

Passage 3

Your firm failed to establish adequate laboratory controls and specifications for your TrustRX Medical Grade Hand Sanitizer drug product. Specifically, you failed to perform microbial testing and impurity testing on your finished hand sanitizer drug products. Without testing each lot prior to release, you did not have scientific evidence that all drug product lots conformed to the appropriate quality specifications.

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.