1Quality unit oversight
In-process materials are not tested for quality and approved or rejected by the quality control unit during the production process.
Inspection Record
Zydus Lifesciences Limited — FDA 483 Findings
Inspectors Jessica S Estriplet · Brandy N LepageThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the sterilization process.
3Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
5Process validation
Your firm failed to establish 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.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient in that floors and walls are not smooth and/or hard surfaces that are easily cleanable.
7Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
About this record
Extracted automatically from the document US FDA published on 2026-08-05. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
