USFDA Inspects Monroe Manufacturing Plant
New Delhi, Jun 18 (PTI) - Glenmark Pharmaceuticals announced on Wednesday that the US health regulator has issued a Form 483 with five observations after inspecting its Monroe manufacturing plant in the US. The US Food & Drug Administration (USFDA) conducted a Good Manufacturing Practice (GMP) inspection at the company’s manufacturing facility situated in Monroe, North Carolina from June 9 to June 17, 2025, the Mumbai-based drugmaker said in a regulatory filing.
At the end of the inspection, the company was issued a Form 483 with five observations, all of which are procedural in nature, with no observation related to data integrity. Glenmark Pharmaceuticals stated that they will work closely with the agency to address the observations and will respond to the USFDA within the stipulated timeline.
According to the USFDA, Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Shares of the company were trading 0.22 per cent up at Rs 1,657.35 apiece on BSE. PTI MSS DRR
