USFDA issues warning letter to Granules India Gagillapur facility

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-02-27T17:41:48+05:30 | Updated On 27 Feb 2025 5:41 PM IST

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Telangana: Granules India has announced that the US Food and Drug Administration (US FDA) has issued a Warning Letter to the Company's Gagillapur facility based on its inspection conducted in August 2024.

"The FDA has not indicated any further escalation. We will respond within the stipulated timeframe and seek a meeting with the FDA to demonstrate ongoing progress towards compliance. We remain confident that this matter will be resolved satisfactorily within a reasonable timeframe," the Company stated in a BSE filing.

Manufacturing and distribution of existing products from the Gagillapur facility continue unaffected. However, the Warning Letter may temporarily impact the FDA review of pending product submissions from this site until the issue is resolved.

The inspection was conducted from 26th August to 6th September 2024.

In September 2024, USFDA issued six observations for the Company's Gagillapur facility in Hyderabad. In December 2024, the facility received “Official Action Indicated” status. The classification of "Official Action Indicated" (OAI) remains, but the regulator has not signaled any further escalation, cnbctv18 reported.

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

"Following the FDA audit and six Form 483 observations, Granules has implemented a proactive and comprehensive remediation plan to strengthen compliance and reinforce product quality and safety at the Gagillapur site. As part of this initiative, we voluntarily paused manufacturing and dispatches in September to conduct a thorough risk assessment, ensuring no product contamination or patient safety concerns. Operations resumed following this assurance. Our remediation plan encompasses comprehensive corrective and preventive actions (CAPAs), oversight by three independent consulting firms, continuous product testing, and monthly updates to the FDA," Granules added.

"Since September 2024, these independent consulting firms— that are subject matter experts in quality, compliance, and regulatory practices—have been engaged to assess and validate the effectiveness of our remediation efforts. They continue to collaborate closely with Granules, both on-site and remotely, to drive sustainable improvements and ensure long-term compliance.

The Warning Letter highlights four key areas previously outlined in the FDA Form 483 observations. Granules has made significant progress addressing all of the FDA observations across these four areas, _ with most corrective actions completed and the remaining ones on track as scheduled. Granules has been providing regular updates to the FDA on the progress and effectiveness of these remediation measures through regular monthly updates. A key focus of these efforts remains risk mitigation, ensuring that there is no adverse impact on the safety or quality of products manufactured and distributed from the Gagillapur facility.

Granules’ growth trajectory remains robust and diversified, underscoring that our strategy is not solely dependent on new product approvals from the Gagillapur site. Key drivers include new launches from our GPI facility in the US, growth from large-volume products in the US and Europe, capacity addition and commercialization of the greenfield formulation facility at Genome Valley, value chain advancements in Europe, and our expanding oncology pipeline from Unit V. These initiatives ensure sustained performance as we work towards resolving the Warning Letter status and reinforcing our commitment to compliance," it said.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751