1Material and supplier control
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Inspection Record
Cipla Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
3Laboratory and QC controls
Established test procedures are not followed.
4Equipment 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.
5Laboratory and QC controls
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
6Laboratory and QC controls
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
7Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
About this record
Extracted automatically from the document US FDA published on 2018-03-27. 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.
