FDA 483 - Intas Pharmaceuticals Limited - December 02, 2022

The FDA Form 483 documents multiple violations at an unnamed facility, indicating significant deficiencies in laboratory practices, quality control, and manufacturing processes.

**Laboratory and Quality Control Issues:** * **Incomplete Data:** Laboratory records lack complete data from tests necessary for specification compliance. * **Inaccurate Environmental Monitoring:** Environmental monitoring samples were inaccurately counted, with reported results less than actual colony counts. A practice of counting merged colonies as one led to undercounting. * **Missing Raw Data:** Printouts, used as raw data, could not be provided for review during reconciliation of analysis performed on January 13, 2021, for instrument SC1111. * **Unfollowed Procedures:** Established test procedures and laboratory control mechanisms are not consistently followed. * **Uncontrolled Data Integration:** No procedure exists for manually entered integration events in chromatography data, and reviewers only examine final chromatograms, not original ones, to justify manual changes. * **Quality Unit Failure:** The Quality Control Unit's responsibilities and procedures are not fully followed, demonstrating a "cascade of failure" in managing GMP documents critical for drug product safety and effectiveness. * **Unvalidated Test Methods:** The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established. * **Inadequate Computer Controls:** Controls over computer systems are insufficient to ensure only authorized personnel institute changes to master production and control records.

**