Shiva Analyticals Private Limited

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 did not adequately investigate out-of-specification (OOS) results. Your investigations into laboratory incidents and OOS results lacked adequate scientific rationale to support root cause determinations and did not extend into previously analyzed batches. New test results were used as the basis for invalidating OOS results without also performing an adequate root cause investigation.

Passage 3

Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures applicable to the quality control unit (21 CFR 211.22(d)).