Inspection Record

Cipla Limited — FDA 483 Findings

US FDAInspected 2016-08-30Published 2016-11-29 4 findingsComplaint and recall handlingAseptic processing and sterility assuranceEquipment and facilityDeviation, CAPA, and investigation

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

Findings

1Complaint and recall handling

An Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.

2Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written and followed.

3Equipment and facility

Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.

4Deviation, CAPA, and investigation

Investigations of an unexplained discrepancy anda failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product.

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.

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