USFDA red flag to Torrent Pharma's Indrad facility
New Delhi: The US health regulator has red-flagged Torrent Pharmaceuticals for significant violations of current good manufacturing practice (CGMP) regulations at its Indrad facility in Gujarat. The United States Food and Drug Administration (USFDA) had inspected the facility from April 8 to 16, 2019.
In a warning letter issued by the regulator to Torrent Pharma's CEO Samir Mehta, the regulator said, "Your firm failed to follow written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess."
It asked the company to provide a detailed summary of its validation program for ensuring a state of control throughout the product life-cycle, along with associated procedures.
Another issue raised by the regulator was that the drug firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.
Stating that company's investigations into testing results were inadequate, the letter said this is a repeat observation from USFDA's April 17-28, 2017, inspection at the Indrad facility.
The USFDA also cited a similar CGMP observation for inadequate investigations at the company's Dahej facility at an inspection during March 11-19, 2019.
"Repeated failures at multiple sites demonstrate that executive management oversight and control over the manufacture of drugs is inadequate," it added.
The regulator has asked the company to provide a retrospective, third-party review of all invalidated results for products currently in the US market and within expiry as of the date of the letter, and a report summarising the findings of the analysis.
While acknowledging that the company has hired a consultant, the regulator asked it to engage a consultant that could assist the firm in meeting CGMP requirements.
"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 refusing admission of articles manufactured at the Indrad plant into the US, it added.