Inspection Record

Strides Shasun Limited — FDA 483 Findings

US FDAInspected 2017-05-26Published 2017-06-05 3 findingsDeviation, CAPA, and investigationLaboratory and QC controlsProcess validation

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

Findings

1Deviation, CAPA, and investigation

Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.

2Laboratory and QC controls

Samples taken of in-process materials for determination of conformance to specifications are not repre- sentative.

3Process validation

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

About this record

Extracted automatically from the document US FDA published on 2017-06-05. 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.

Strides Shasun Limited company profile — full history US FDA documents, 2017 Go to Findings search