Inspection Record

Cipla Ltd. — FDA 483 Findings

US FDAInspected 2018-04-13Published 2018-04-20 3 findingsProcess validationLaboratory and QC controlsStability and storage

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

Findings

1Process validation

Written procedures for production and process controls are not designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

2Laboratory and QC controls

Scientifically sound and appropriate laboratory control mechanisms are not established to assure that n- process materials or drug products conform to appropriate standards of identity, strength, quality and purity.

3Stability and storage

Testing programs are not adequately designed to assess the stability characteristics of drug products.

About this record

Extracted automatically from the document US FDA published on 2018-04-20. 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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Cipla Ltd. company profile — full history US FDA documents, 2018 Go to Findings search