Granules India’s Gagillapur Facility Receives USFDA Warning Letter

27 Feb 2025 , 11:16 PM

Granules India Ltd’s Gagillapur facility receives Warning Letter from US FDA after an inspection in August 2024. The Warning Letter is dated February 26, 2025 and the facility continues to hold an “Official Action Indicated” (OAI) status. But the FDA has not signaled any further escalation at this point.

Granules India, maintaining that it fully intends to respond in the time period allowed, as well as requesting a meeting with the FDA to show progress made in compliance, has taken care to make this clear as well.

In December 2024, the company had said the Gagillapur facility is classified as OAI by US FDA. This came after Form 483 was issued in September 2024 with six observations that need corrective action.

“The Warning Letter may cause a temporary elevation in the queue of pending approvals for products manufactured at Gagillapur for FDA review. However, the continued manufacture and distribution of existing products made at the facility are unaffected.

Granules India has complied with a comprehensive corrective action plan, as also reported by the FDA. The plan involves corrective and preventive actions (CAPAs), supervision by three independent consulting firms, ongoing product testing, and monthly progress reports to the F.D.A.

Following the FDA’s observations, the company proactively suspended its production and shipments from the Gagillapur facility in September 2024. Operations were resumed only after a thorough risk assessment, ensuring there was no risk to human health from contamination.

The Warning Letter thus focuses on four main areas raised in the earlier Form 483 observations. Granules India has provided substantial evidence of how it is striving to resolve all the issues identified, including having already fully implemented most corrective actions identified, and that remaining actions are progressing to plan.

The company is continuing to update the FDA on the effectiveness of its remediation efforts on a regular basis. These steps are designed to mitigate risk so that the safety and quality of Redditch manufactured products continues to be held at the industry-leading standards that are expected with any of our facilities including Gagillapur.

Even as the Gagillapur facility is struggling with regulatory issues, Granules India is not shying away from its long-term growth outlook. Going forward, the company anticipates robust growth from new product launches from the GPI facility in the US, an increase in capacity at Genome Valley, expanded manufacturing in Europe and an expanding oncology pipeline from Unit V.