Inspection Record

Invitro Research Solutions Private Ltd — FDA 483 Findings

US FDAInspected 2025-12-18Published 2026-07-28 4 findingsProcess validationLaboratory and QC controlsDeviation, CAPA, and investigation

Inspectors Zachary L StammThe inspectors who signed the published document.Inspector lookup

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

Findings

1Process validation

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.

2Laboratory and QC controls

The written stability program for drug products does not include reliable, meaningful and specific test methods.

3Deviation, CAPA, and investigation

Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.

4Laboratory and QC controls

Laboratory records do not include complete data derived from all tests, examinations and assay necessary to 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.

Invitro Research Solutions Private Ltd company profile — full history US FDA documents, 2026 Go to Findings search