Intas Pharmaceutical's facility has been handed an FDA warning letter after the agency found multiple violations of current good manufacturing practice (CGMP) regulations at its Gujarat, India site.
During the inspection, which took place from November 22 to December 02, 2022, the agency identified violations that included failure to ensure drug products' quality, accuracy, and integrity, inadequate data integrity practices, and lack of effective quality system oversight.
The agency raised concerns about Intas’ failure to establish and follow required laboratory control mechanisms, inadequate validation of manufacturing processes, and lack of method validation for testing raw materials. In an concerning revelation, the report noted that an analyst used acetic acid to destroy CGMP records, which included analytical balance slips for testing. But even though a quality control employee reported these incidents to lab management on November 22, 2022, the investigation into the potential impact on drug product quality did not begin until November 28, 2022.
The firm was placed on Import Alert, and FDA requested timely communication regarding any actions that might disrupt drug supply or lead to shortages. Import Alert 66-40 is an FDA alert that targets drugs and pharmaceutical products from foreign companies or facilities found non-compliant with FDA's CGMP regulations. It directs FDA field personnel to detain and refuse admission of products from these entities into the U.S.
Just a few weeks ago, FDA handed Intas Pharmaceuticals another form 483, complete with 16 observations, following the inspection of another one of the company's Gujarat manufacturing facilities.
Primarily focused on generics, Intas produces APIs, oral solid dose products, injectables and plasma products. It operates fourteen manufacturing facilities, with eleven situated in India and the others in the UK and Mexico.