Intas Pharmaceuticals 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

You failed to initiate or conduct adequate investigations into significant deviations in your aseptic processing manufacturing operations. You lacked investigations into visual inspection failures and non-viable particulates (NVP) exceeding your action levels. When investigations were conducted, they were often insufficient and lacked scientifically supported root cause(s).

Passage 3

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

Passage 4

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113 (b)).