Firm Record

Zydus Lifesciences Limited findings history

27 findings from 5 inspection documents published by regulators. Each row below says what its date means.

US FDA 2024-04-12 ~ 2026-08-05 5 documents 27 findings

Areas cited

Aseptic processing and sterility assuranceProcess validationEquipment and facilityDeviation, CAPA, and investigationLaboratory and QC controlsQuality unit oversightTraining and personnelComplaint and recall handlingComputer system validation

Published inspection documents

2026-08-05 US FDA 7 findingsQuality unit oversight · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Process validation · Computer system validation In-process materials are not tested for quality and approved or rejected by the quality control unit during the production process. 2025-10-30 US FDA 4 findingsLaboratory and QC controls · Quality unit oversight · Equipment and facility · Complaint and recall handling Reserve samples from representative sample lots or batches of diug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration. 2024-09-10 US FDA 3 findingsDeviation, CAPA, and investigation · Process validation · Aseptic processing and sterility assurance 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). You failed to adequately investigate contamination identified in your drug products. Cross-contamination Over approximately 3 months, you experienced multiple cross-contamination events. Your firm identified cross-contamination from (b)(4) drug product… 2024-04-29 US FDA 9 findingsLaboratory and QC controls · Aseptic processing and sterility assurance · Training and personnel · Process validation · Equipment and facility · Deviation, CAPA, and investigation Established sampling plans and test procedures are not followed. 2024-04-12 US FDA 4 findingsAseptic processing and sterility assurance · Equipment and facility Procedures designed to prevent microbiological contamination of diug products purpo1i ing to be sterile are not written and followed.

About this page

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.

What is included. As of 2026-09-03, only documents that have a detail page (at least 3 findings) are listed. The company may have more documents; the full set is available in Company lookup below.

Companies are grouped by a normalised key, not the displayed name — “… Limited” and “… Ltd.” count as the same company. Translation and classification are automated and may differ in nuance from the source; the basis for judgement is always the regulator's published document.

Full history of Zydus Lifesciences Limited — including inspection classifications Browse by document Go to Findings search