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USFDA issues warning letter to Telangana unit of Vista Pharmaceuticals

The warning letter is issued in violations of current good manufacturing practice regulations

Press Trust of India  |  Hyderabad 

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The has issued a warning letter to the facility of the city-based Ltd, for "significant violations" of current good practice (CGMP) regulations for finished

The (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 summarizes significant of current good practice (CGMP) regulations for finished See 21 CFR, parts 210 and 211," the letter said.

"Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug 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, Managing Director of Ltd.

The company officials were not available for comments.

"The 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 added.

"Failure to correct these may also result in refusing admission of manufactured at the facility into the under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3)," it added.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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