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FDA Warning Letter Explorer
FDA warning letter · Drugs

Handock Cosmetics Co., Ltd.

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 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 21 CFR 211.84(d)(2)).

Passage 2

Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).

Citations in the original letter

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

  • 21 CFR 201.128
  • 21 CFR 207.41
  • 21 CFR 207.57(b)(iii)
  • 21 CFR 207.29
  • 21 CFR 210
  • 21 CFR 211.84(d)(1)
  • 21 CFR 211.84(d)(2)
  • 21 CFR 211.22
  • 21 CFR 211.63
  • 21 CFR 330