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FDA Warning Letter Explorer
FDA warning letter · Drugs

Seoul 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 establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacture of your over-the-counter (OTC) drug products intended for the U.S. market. For example, you failed to ensure:

Passage 2

Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Citations in the original letter

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

  • 21 CFR 201.128
  • 21 CFR 210
  • 21 CFR 211.22
  • 21 CFR 211.165(e)
  • 21 CFR 211.166(b)
  • 21 CFR 211.84(d)(1)
  • 21 CFR 211.100(a)
  • 21 CFR 330.1