FDA 483 - Ipca Laboratories Limited - July 14, 2014

The FDA inspection of IPCA Laboratories, Ltd. in Ratlam, India, revealed severe data integrity issues within their QC Analytical and Microbiology laboratories, including manipulation of test results, back-dating of records, and falsification of samples. The firm also failed to adequately train personnel, maintain stable incubation conditions, properly evaluate reprocessing of non-conforming batches, and assess critical production deviations. These findings indicate significant deficiencies in the firm's quality control and manufacturing practices.