BotableBook a call
FDA Warning Letter Explorer
FDA warning letter · Drugs

Revlon Group Holdings, LLC

Issued · Posted by FDA

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 test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 21 CFR 211.84(d)(2)).

Passage 2

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 inspect to verify that you have completed corrective actions to address any violations.

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 211.84(d)(2)
  • 21 CFR 211.84(d)(1)
  • 21 CFR 211.22
  • 21 CFR 211.160(b)