Glenmark Receives USFDA Form 483 for Monroe Manufacturing Unit

• Glenmark receives five procedural observations in USFDA Form 483
• No data integrity issues were identified during the Monroe plant inspection
• Company shares rose 0.22% post-inspection disclosure

Glenmark Pharmaceuticals announced on Wednesday that the US FDA issued a Form 483 with five procedural observations after an inspection of its Monroe Manufacturing Facility in North Carolina, USA. The GMP inspection took place between June 9 and June 17, 2025.

In its regulatory filing, Glenmark stated that all five observations by the US FDA were procedural and did not include any data integrity observations. It was reported that Glenmark is fully committed to resolving the observations in compliance with regulatory expectations, and would provide a response within the required timeframe.

A Form 483 is usually issued at the end of an inspection when investigators observe conditions that may violate the Food, Drug, and Cosmetic Act (FD&C Act), or other regulations. A Form 483 is a formal notification to the firm's management to enable them to promptly address the identified issues.

Also Read: Enhancing Clinical Trial Supply Chain Resilience to Address Global Disruptions in India

Despite the issuance of Form 483, Glenmark shares remained relatively unaffected and gained a little during the trading day, with the stock trading at ? 1,657.35, up 0.22%, on the Bombay Stock Exchange (BSE) following the news, indicating that most investors in the stock were less concerned about the procedural observations.

Glenmark emphasized that it is committed to maintaining global quality and compliance standards across its global operations and will work with the USFDA to resolve the observations.