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FDA Warning Letter Explorer
FDA warning letter · Drugs

Yangzhou Sion Commodity 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 test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. 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 ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).

Citations in the original letter

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

  • 21 CFR 210
  • 21 CFR 211.84(d)(1)
  • 21 CFR 211.84
  • 21 CFR 211.22
  • 21 CFR 211.165(b)
  • 21 CFR 211.166
  • 21 CFR 211.25(a)
  • 21 CFR 211.194(a)