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FDA Warning Letter Explorer
FDA warning letter · Drugs

Tentamus India Private 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 thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Passage 2

Your firm failed to document at the time of performance required laboratory control mechanisms (21 CFR 211.160(a)).

Citations in the original letter

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

  • 21 CFR 210
  • 21 CFR 211.22
  • 21 CFR 211.192
  • 21 CFR 211.160(a)