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FDA Warning Letter Explorer
FDA warning letter · Drugs

Erkul Kozmetik Sanayi ve Ticaret A.S.

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)).

Citations in the original letter

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

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