Inspection Record

Cadila Healthcare Limited — FDA 483 Findings

US FDAInspected 2022-03-10Published 2022-03-18 3 findingsEquipment and facilityQuality unit oversightStability and storage

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

Findings

1Equipment and facility

Buildings used in the manufacturing and processing of a diug product are not maintained in a good state of repair.

2Quality unit oversight

Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number ofbatches, whether approved or rejected.

3Stability and storage

The written stability testing program is not followed.

About this record

Extracted automatically from the document US FDA published on 2022-03-18. 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

2019-05-03 · US FDA · 14 findings
Cadila Healthcare Limited company profile — full history US FDA documents, 2022 Go to Findings search