The U.S. FDA has handed India-based Intas Pharmaceuticals a form 483, complete with 16 observations, following the inspection of one of the company's Gujarat manufacturing facilities.
The inspection, which took place from May 1 to May 12, 2023, revealed multiple observations related to Intas' manufacturing process. The agency noted deficiencies in equipment maintenance, quality control procedures, data integrity, and cleanliness standards, among others.
One of the key findings was the lack of adequate controls and procedures to ensure the cleanliness of equipment. The FDA noted instances where previous batch identifications were not properly removed or obliterated, raising concerns about potential cross-contamination.
The inspection also identified deficiencies in the quality control unit's responsibilities and procedures, noting ineffective supervisory oversight over quality and production operations. This lack of oversight extended to the review of production data, conducting investigations, and adhering to written procedures.
The FDA observed non-compliance with proper environmental monitoring practices. Routine identification of microorganisms in the purified water system was lacking, and the identification of certain Gram-negative organisms was not followed up with further investigation, posing potential risks for contamination in the manufacturing process.
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. The drugmaker was hit late last year with an 11-observation 483 following the inspection of a different facility in Gujarat. The 483 was followed by an Import Alert.