1Laboratory and QC controls
Laboratory failures are not thoroughly investigated.
Inspection Record
Divi's Laboratories Ltd. Unit II — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Your firm failed to test individual batches of final API for conformity with all appropriate specifications such as purity, strength, and identity prior to Specifically, your firm does not analyze for assay for all final API batches prior to The following final API products were found to not be analyzed for assay: ‘Active Pharmaceutical Number of final batches not | Number of final batches not Ingredient analyzed for Assay prior to | analyzed for Assay prior to (b) (4) P (b) (4) F in2016 in2017 ahi ( DMF 4) batches “=" batches (b) (4) me) DMFH?@ batches batches oe (DMF#O® batches batches a (DMF#®® batches Mb atches Set.
3Deviation, CAPA, and investigation
Review of Analytical incident/excursion investigations as per your Atypical or out of trend results procedure (2- RA/OP/03) showed instances in which samples injection sequence was completed but results were not calculated and/or compared to specification to ensure OOS results were not obtained and sample result screening is not occurring prior to invalidating the run for system suitability or chromatograph issues.
4Documentation and records
Batch records are not always recorded contemporaneously at the completion of an operation.
About this record
Extracted automatically from the document US FDA published on 2017-09-26. 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.
