Inspection Record

Alembic Pharmaceuticals Limited — FDA 483 Findings

US FDAInspected 2016-03-25Published 2016-11-29 4 findingsDeviation, CAPA, and investigationContamination controlProcess validationQuality unit oversight

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

Findings

1Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

2Contamination control

Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established , written and followed.

3Process validation

Written production and process control procedures are not documented at the time ofperformance.

4Quality unit oversight

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

About this record

Extracted automatically from the document US FDA published on 2016-11-29. 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

2021-02-06 · US FDA · 5 findings2021-11-10 · US FDA · 10 findings
Alembic Pharmaceuticals Limited findings history — including this company's other documents US FDA documents, 2016 Go to Findings search