OR WAIT null SECS
FDA sent a warning letter to the company in India for delaying and limiting an FDA inspection in addition to problems related to cGMP.
On April 28, 2017 FDA sent a warning letter to Vikshara Trading & Investments Ltd at Opp: Anup Engineering, Odhav Road, Ahmedabad, Gujarat, India concerning an inspection that occurred on October 18, 2016. According to the warning letter, the company delayed and limited an FDA inspection.
According to FDA, the company committed several 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 drugs are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B),” FDA wrote in a warning letter to the company.
FDA said that Vikshara Trading & Investments Ltd delayed attempts to schedule a pre-announced inspection. The company told FDA that their factory workers and staff had gone on strike and blocked off the entrance to the facility, causing FDA to cancel a pre-announced inspection. FDA wrote, “despite your assertions that your employees were on strike, FDA obtained evidence that your firm actively manufactured numerous products, including at least (b)(4) batches of drugs, between July 11, 2016 and August 9, 2016.”
During an inspection on Oct. 18, 2017, FDA said the company “significantly hindered FDA from fully assessing your compliance with CGMP.” The company did not provide batch records to FDA, and the warning letter states that during the inspection the lights were off in the facility.
“In those areas that were physically accessible, our investigator had to perform parts of the walkthrough in the dark, using a flashlight,” FDA wrote in the warning letter. “Even with limited visibility, our investigator observed (b)(4) powder scattered throughout the production areas, including powder caked on the floor. In addition, our investigator observed empty boxes, trash, finished drug products covered in powder, and containers littered throughout the facility.”
FDA placed the firm on Import Alert 66-40 on February 8, 2017 and Import Alert 99-32 on February 9, 2017. The company has 15 days within receiving the letter to respond to FDA.