Inspection Record

Biocon Sdn Bhd — FDA 483 Findings

US FDAInspected 2020-02-21Published 2020-04-02 3 findingsAseptic processing and sterility assuranceDeviation, CAPA, and investigationQuality unit oversight

Inspectors Vidya B PaiThe inspectors who signed the published document.Inspector lookup

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

Findings

1Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of diug products purpo1iing to be sterile are not established and followed.

2Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been aheady distributed.

3Quality unit oversight

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

About this record

Extracted automatically from the document US FDA published on 2020-04-02. 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.

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Biocon Sdn Bhd company profile — full history US FDA documents, 2020 Go to Findings search