Glenmark’s investigations did not adequately address the scope and cause of these “serious” defects and evaluate other products with similar “manufacturing quality signals” or the same supplier, the FDA found.
The US Food and Drug Administration’s (US FDA), in a warning letter to Glenmark Pharmaceuticals earlier this month, said that the generic drug maker failed to thoroughly investigate issues related to the quality of some of its products.
According to the letter issued to Glenmark, the company “failed to adequately investigate more than 70 consumer complaints associated with punctures, cracks, and holes” in some of the topical creams and ointments manufactured at its Baddi facility.
Glenmark’s investigations did not adequately address the scope and cause of these “serious” defects and evaluate other products with similar “manufacturing quality signals” or the same supplier, the FDA found.
“In your response, you stated that the root cause for the complaints was improper ‘handling by folding and refolding of the (redacted)’ by consumers. In addition, you stated that because the complaint rate is insignificant, there is no risk to marketed batches,” it stated, adding over 50 complaints were closed “without” a plan to prevent these issues in the future. “Your quality system for investigations is inadequate and does not ensure consistent production of safe and effective products,” it told the firm.
Glenmark’s investigation of and response to “multiple” complaints of “grittiness” of one of its topical creams was also “inadequate”. In July, the firm recalled an undisclosed number of batches of its mometasone furoate cream (used to treat various skin conditions) from the US over their grittiness — an “ongoing formulation issue since 2010” also flagged in previous inspections.
“In your response to the most recent inspection, you stated that the product grittiness issue was remediated during product reformulation in November 2018. Your response is inadequate. You did not provide sufficient data to demonstrate the robustness of the new formulation,” stated the warning letter.
In a separate warning letter on October 8, the US regulator told Torrent to “immediately and comprehensively” assess its global manufacturing operations to ensure it conformed to FDA requirements. “Repeated failures at multiple sites demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” it told Torrent. The firm had failed to “thoroughly” investigate unexplained discrepancies or failures of products made at its Indrad facility, including its high blood pressure drug losartan potassium and hydrochlorothiazide tablets. It had closed “multiple” out-of-specification (OOS) investigations “without assignable root cause” or “adequate scientific justification” of these causes. “Despite the inadequate OOS investigations, your firm disregarded initial failing OOS results and released batches based on retested results,” the FDA told the company.
Issues were also raised for Torrent’s Dahej facility during an inspection in March, the regulator said. Glenmark and Torrent had notified the BSE earlier this month of the warning letters they had received. Both firms said that the letters would not have an impact on their operations, and they were working to resolve the issues.
Written by Prabha Raghavan | New Delhi