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FDA Warning Letter Explorer
FDA warning letter · Drugs

Zydus Lifesciences Limited

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 withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined, as appropriate, and failed to test samples for conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84).

Citations in the original letter

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

  • 21 CFR 211.84
  • 21 CFR 211.22