Intas Pharmaceuticals Limited
4 extracted findings
FDA source excerpt, selected passage
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).
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
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).
Source passage selected by the model
02
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).
Source passage selected by the model
03
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)).
Source passage selected by the model
04
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)).
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.