USFDA issues warning letter to Hyderabad-based Vista Pharma
Hyderabad: The USFDA has issued a warning letter to the manufacturing facility of the city-based Vista Pharmaceuticals Ltd, for “significant violations” of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
The US Food and Drug Administration (FDA) officials had visited the facility located at APIIC Industrial Estate, at Gopalapalli in Nalgonda district in Telangana, from 19-23 September 2016.
“This warning letter summarizes 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 5 July and addressed to Dhananjaya Alli, managing director of Vista Pharmaceuticals Ltd. 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.
- Sun Pharma recalls 2 lots of diabetes drug in US over microbial contamination
- Narendra Modi govt to step beyond renewable goal with China-scale tenders
- IAF trainer aircraft crashes near Siddipet in Telangana, woman pilot safe
- Islamabad protest turns violent as police fire tear gas to break up sit-in
- Donald Trump says he turned down Time’s ‘Person of the Year’