USFDA inspected Glenmark's Monroe site (June 9-17, 2025) and issued a Form 483 with five procedural observations; the company is to respond promptly, and no data integrity issues.

• USFDA conducted a June 9-17, 2025, GMP inspection at the Monroe site, issuing Form 483.
• Five procedural observations noted; none relate to data integrity, per Glenmark.
• The company is to collaborate with the USFDA, submit a response within the timeline, and ensure compliance.