FDA sent a warning letter, dated Dec. 3, 2018, to Skylark CMC Pvt. Ltd. after employees at the company’s Ahmedabad, Gujarat, India facility refused to let FDA inspectors to perform an inspection on the facility. According to FDA, the investigators were prevented from entering the manufacturing area. Skylark CMC Pvt. Ltd employees also refused to provide FDA with copies of manufacturing and shipping records. According to the warning letter, the FDA inspection was instigated after the agency suspected that the facility was located at the same address of Vikshara Trading & Investments Ltd, which the agency says is on FDA Import Alert 99-32, “Detention Without Physical Examination of Products from Firms Refusing FDA Foreign Establishment Inspection.”
“FDA placed your firm on Import Alert 99-32 on November 8, 2018 … Until FDA is permitted to inspect your facility and confirms compliance with CGMP, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Skylark CMC Pvt. Ltd. near Electric Sub Station, Odhav Road, Ahmedabad, Gujarat, into the United States are subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3),” the agency stated in the letter.