"FDA Tightens Grip: Mixed Bag for Indian Pharma in June 2025 Inspections"

Halol facility in Gujarat underwent a US FDA inspection from June 2–13, 2025, resulting in eight Form 483 observations. This site has a history of regulatory scrutiny and remains under an import alert since 20222. formulations unit in Kothur, Hyderabad was inspected from June 9–19, 2025. The US FDA issued seven observations in Form 483. Natco has stated it will address these within the stipulated timeline4. India’s Bonthapally API facility completed its inspection on June 20, 2025, with just one observation, a relatively positive outcome compared to peers. These inspections reflect the US FDA’s continued focus on Good Manufacturing Practices (GMP) compliance. While some companies face setbacks, others like Granules India appear to be improving their regulatory track record.