Hyderabad-based Vista Pharmaceuticals has been issued a warning letter over significant violations of good manufacturing norms at its Nalgonda facility in Telangana, according to the US health regulator USFDA.
The warning letter was issued to the company after finding various non-compliance of norms, including failure to clean, sanitise and sterilise equipment and utensils used in manufacturing drugs, during an inspection of the facility from September 19 to 23, 2016, the US Food and Drug Administration (USFDA) said.
In its letter to Vista Pharmaceuticals Managing Director Dhananjaya Alli, the USFDA 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 the Federal Food, Drug, and Cosmetic Act.
The regulator said its investigators observed that some equipment were in a state of disrepair with holes and corrosion during the inspection.
The failure to clean, sanitise and sterilise equipment and utensils at appropriate intervals to prevent malfunctions or contamination would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements, it said.
The USFDA said the company should conduct and provide the results of a retrospective review of all drugs within expiry distributed to in the US that were manufactured on equipment identified as in a state of disrepair.
Moreover, the company failed to establish written procedures for production and process control designed to assure that the drugs have the identity, strength, quality, and purity that they purport, the regulator added.
The USFDA also pulled up the company for 'misbranding violation' over the firm's isoxsuprine hydrochloride tablets, which "appear to be identical, related, or similar to Vasodilan tablets", the approval for which was withdrawn effective March 13, 2009.
"There is no FDA approved application on file for your product," the warning letter said.
Asking the company to rectify the violations, the letter said, "Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer."
Failure to correct these violations may also result in FDA refusing admission of articles manufactured at Vista Pharmaceuticals Ltd at Nalgonda, Telangana, into the United States, it added.
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