USFDA red flags GPT Pharmaceuticals for significant violations at Hyderabad unit
In a warning letter to the company's MD Ashok Adityan, USFDA said during inspection of the facility, its investigators observed specific violations, including failure by the company's quality control unit 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, the United States Food and Drug Administration (USFDA) 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, sanitize and/or sterilize 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.
It asked the company to provide its corrective and preventive action (CAPA) plan to implement routine, vigilant operations management oversight of facilities and equipment.
Highlighting another violation, USFDA said, "Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records."
Another important issue red flagged by the US health regulator pertained to data integrity.
"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.
It asked the company to initiate a comprehensive investigation into the extent of the inaccuracies in data records and reporting.
"Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new drug applications or supplements listing your firm as a drug manufacturer," the letter said.
Failure to correct these violations may also result in the FDA continuing to refuse admission of articles manufactured at GPT Pharmaceuticals' Hyderabad facility into the US, it added.
The USFDA has asked the company to respond in writing within 15 working days specifying what it has done since the inspection to correct the violations and to prevent their recurrence. AKT ABM