1Laboratory and QC controls
Established sampling plans, test procedures and laboratory control mechanisms are not documented at the time of performance.
Inspection Record
Sun Pharmaceuticals Industries Limited — FDA 483 Findings
Inspectors Justin A Boyd · Teresa I Navas · Jonah S UfferfilgeThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
3Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
4Laboratory and QC controls
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
5Material and supplier control
Written procedures are not followed for the testing of components.
6Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
About this record
Extracted automatically from the document US FDA published on 2022-08-18. 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.
