The warning letter summarises significant violations of CGMP regulations
The US Food and Drug Administration (FDA) has issued a warning letter to the manufacturing facility of the Hyderabad-based Vista Pharmaceuticals, for ‘significant violations’ of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
The US FDA officials had visited the facility located at APIIC Industrial Estate, at Gopalapalli in Nalgonda district in Telangana, from September 19 to 23, 2016.
“This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211,” the FDA letter said.
“Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products 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),” it said.
The letter was issued on July 5 and addressed to Dhananjaya Alli, MD, Vista Pharmaceuticals.
The company officials were not available for comments.”The violations cited in the letter are not intended as an all-inclusive list and the company is responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations,” the FDA added.
“Failure to correct these violations may also result in FDA refusing admission of products manufactured at the facility into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3),” it added.