Inspection Record

Reliance Life Sciences Private Limited — FDA 483 Findings

US FDAInspected 2026-02-27Published 2026-07-28 3 findingsDeviation, CAPA, and investigationAseptic processing and sterility assuranceLaboratory and QC controls

Inspectors Eileen A. Liu · Ashar P. ParikhThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Deviation, CAPA, and investigation

Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.

2Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.

3Laboratory and QC controls

Laboratory records do not include complete data derived from all tests, examinations, and assay necessary te assure compliance with established specifications and standards.

About this record

Extracted automatically from the document US FDA published on 2026-07-28. 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.

Reliance Life Sciences Private Limited company profile — full history US FDA documents, 2026 Go to Findings search