Inspection Record

Indoco Remedies Limited — FDA 483 Findings

US FDAInspected 2019-06-04Published 2019-07-09 3 findingsMaterial and supplier controlDeviation, CAPA, and investigationStability and storage

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

Findings

1Material and supplier control

Written procedures are not established that describe the examinations to be conducted on appropriate samples of in-process materials ofeach batch.

2Deviation, CAPA, and investigation

Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches ofthe same drug product.

3Stability and storage

There is no written testing program designed to assess the stability characteristics of drug products.

About this record

Extracted automatically from the document US FDA published on 2019-07-09. 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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