The U.S. Food and Drug Administration has pulled up Intas Pharmaceuticals Ltd. for manufacturing lapses, including violation of current good manufacturing practice regulation, at its Ahmedabad-based plant.
In a warning letter to the company’s Chief Executive Officer and Managing Director Nimish Chudgar, the U.S. health regulator has pointed out various manufacturing lapses at the Matoda-Sanand, Ahmedabad-based facility. A warning letter is issued when the U.S. health regulator finds that a manufacturer has significantly violated its regulations. The U.S. FDA inspected the facility from May 1-12, 2023
This warning letter summarises significant violations of CGMP regulations for finished pharmaceuticals…Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated,” it noted.
In the warning letter, the health regulator pointed out the company “failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity”. It also noted that the company’s Quality Assurance and production departments failed to provide adequate oversight and ensure the reliability of
data related to the quality of finished drug products manufactured at the facility.