Apart from drugs and drug-related products, the list of items to be detained without physical examination include categories such as food sweeteners, antimicrobial agents, antioxidants, fumigants, ph control agents and oral hygiene products. The import alert was issued as the factory did not follow USFDA-mandated good manufacturing practices (cGMP).
The unlisted company's facility had been inspected in April 2013, after which it received two Form 483s, according to information from the USFDA. The same unit then received a warning letter in February 2014 which said the deviations identified in the cGMP caused active pharmaceutical ingredients (APIs) manufactured at the location to be adulterated.
The February-dated warning letter had listed 11 observations including failure to perform laboratory testing of APIs in the required method, failure to maintain complete data records of laboratory tests conducted, inadequate cleanliness of equipment, failure to properly investigate customer complaints, among others.
The company, established in 1981, has four facilities located in the Baroda location which manufactures pharmaceuticals, specialty chemicals and mineral fortifiers, according to its website. The company lists top U.S. Pharmaceutical companies such as Mallinckrodt Pharmaceuticals and Thermo Fisher Scientific laboratory supplying arm, Fisher Scientific as its customers.