Inspection Record

Piramal, Piramal Pharma Limited — FDA 483 Findings

US FDAInspected 2025-02-17Published 2025-03-06 5 findingsQuality unit oversightEquipment and facilityDeviation, CAPA, and investigationComplaint and recall handlingDocumentation and records

Inspectors Guerlain UlysseThe inspectors who signed the published document.Inspector lookup

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

Findings

1Quality unit oversight

The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

2Equipment and facility

The cleaning ofequipment is inadequate.

3Deviation, CAPA, and investigation

Written records of investigation of an active pharmaceutical ingredient (API) do not include follow-up.

4Complaint and recall handling

Written records of investigation ofan API complaint do not include adequate follow-up.

5Documentation and records

Master production and control records lack complete manufacturing and control instructions, written specifications, and precautions to be_followed.

About this record

Extracted automatically from the document US FDA published on 2025-03-06. 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.

Piramal, Piramal Pharma Limited company profile — full history US FDA documents, 2025 Go to Findings search