Glenmark Addresses USFDA Inspection Observations

  Published 11 months ago

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.

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