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GPT Pharma gets US FDA warning for cGMP violations at Hyderabad plant

Our Bureau, Mumbai
Monday, January 6, 2020, 13:00 Hrs  [IST]

The United States Food and Drug Administration (FDA) has issued warning letter to drug firm GPT Pharmaceuticals for significant violations of current good manufacturing practice (cGMP) at its Hyderabad plant.

In a warning letter to the company's MD Ashok Adityan, US FDA said during inspection of the facility, its investigators observed that firm’s quality control unit failed to exercise responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity.

The inspection was conducted from June 24 to 28, 2019 and significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals were observed, US FDA said.

The regulator said it has reviewed company's July 17, 2019 response to its Form FDA 483 in detail and also acknowledged receipt of the firm's subsequent correspondence.

"Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitise and/or sterilise equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements," the regulator said.

US FDA further added, "Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorised personnel institute changes in master production and control records, or other records."

"Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture," the 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)," US FDA said in its letter.


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