Inspection Record

Unichem Laboratories Ltd. — FDA 483 Findings

US FDAInspected 2018-07-27Published 2018-09-10 4 findingsStability and storageCleaning validationLaboratory and QC controls

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

Findings

1Stability and storage

There was no record of stability samples stored in containers that simulate the market container.

2Cleaning validation

Cleaning procedures are not validated.

3Laboratory and QC controls

Test procedures are not scientifically sound and appropriate to ensure that raw materials, intermediates, APIs, and labels and packaging materials conform to established standards of quality and/or purity.

4Laboratory and QC controls

Laboratory controls were not followed and documented at the time of performance.

About this record

Extracted automatically from the document US FDA published on 2018-09-10. 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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Unichem Laboratories Ltd. company profile — full history US FDA documents, 2018 Go to Findings search