Inspection Record

Ipca Laboratories Limited — FDA 483 Findings

US FDAInspected 2025-12-05Published 2026-02-05 3 findingsCleaning validationEquipment and facilityLaboratory and QC controls

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

Findings

1Cleaning validation

There is a lack ofadequate controls in place to minimize the carryover ofthe residual materials into successive batches of the same intermediate or API.

2Equipment and facility

Buildings and facilities used to manufacture APis are not maintained appropriately to facilitate cleaning and to minimize potential contamination.

3Laboratory and QC controls

The suitability of analytical test methods is deficient for its intended use.

About this record

Extracted automatically from the document US FDA published on 2026-02-05. 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.

Other records for this company

2026-05-11 · Health Canada · 5 findings2023-06-23 · US FDA · 7 findings2022-09-26 · Health Canada · 5 findings
Ipca Laboratories Limited findings history — including this company's other documents US FDA documents, 2026 Go to Findings search