FDA WARNING_LETTER - Intas Pharmaceuticals Limited - December 02, 2022

The FDA issued a Warning Letter to Intas Pharmaceuticals Limited following a November 22 to December 02, 2022, inspection of their drug manufacturing facility in Sanand, India. The inspection revealed significant violations of current Good Manufacturing Practice (CGMP) regulations, rendering their drug products adulterated.

Key violations include the quality control unit's failure to ensure CGMP compliance and data reliability. Specific issues involved inadequate oversight of original CGMP documents (e.g., torn and discarded records found in scrap areas), deficient controls over computerized systems (e.g., manual alterations in electronic batch records, unapproved chromatogram reprocessing, unutilized electronic data storage for instruments), and insufficient laboratory investigations (e.g., invalidated OOS results without justification, high number of aborted chromatographic sequences without systemic CAPA).

Additionally, the firm failed to ensure complete laboratory records, with inaccurate environmental monitoring data and missing raw data. They also lacked appropriate procedures for chromatographic peak integration and failed to adequately validate the manufacturing process for certain drug products, omitting a failed process validation batch from reports. Furthermore, the firm did not establish the accuracy, sensitivity, specificity, and reproducibility of test methods for raw materials.

The FDA deemed the company's responses inadequate, citing a lack of comprehensive evaluation of deficiencies and insufficient management oversight. The letter requires detailed corrective actions, including comprehensive investigations into data inaccuracies, a risk assessment, and a global CAPA plan. Repeat observations from previous inspections indicate inadequate executive management