USFDA Hits Intas Pharmaceuticals With Another Warning Letter
The FDA has issued another warning letter to Intas Pharmaceuticals, citing manufacturing violations, quality control lapses, and compromised data integrity at its plant in Ahmedabad, Gujarat, India. The FDA has also added the Indian facility to its import alert list, allowing FDA field operatives to detain products from Intas without physical examination.
The warning letter, dated November 21, points to four main issues identified during a 12-day site inspection in May 2023. The FDA states that Intas failed to ensure that the drug products it manufactures comply with Current Good Manufacturing Practice (CGMP) regulations.
One significant issue highlighted is the manipulation of particle and defect counts on manual visual inspection records by visual inspectors to keep finished product batches within rejection limits. This problem has reportedly been ongoing since 2021.
While Intas voluntarily recalled batches with particle contaminations and disqualified the implicated visual inspectors, the FDA deems the company's response "inadequate." The FDA emphasises that Intas has not thoroughly examined its other CGMP records and has not implemented a comprehensive corrective action and preventative action plan.
The FDA also raised concerns about Intas' failure to thoroughly investigate discrepancies in batches, the lack of written procedures and process controls to ensure product quality, strength, and purity, and the overall absence of a systematic approach to address these issues.
This is the second warning letter Intas has received from the FDA in recent months. In August 2023, the company received a notice for its facility in Sanand, India, citing quality control and data integrity issues, including the destruction of data by an analyst. The Sanand facility was placed on the FDA's import alert list on June 1, 2023. Now, with the Gujarat facility added to the import alert list, both sites are subject to heightened scrutiny by the FDA.
