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As per 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. | Photo Credit: ANDREW KELLY
Glenmark Pharmaceuticals on Wednesday said 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, it added.
All the observations are procedural in nature, it said.
There was no observation related to data integrity, it added.
The company will work in close collaboration with the agency to address the observations and will respond to the USFDA within the stipulated timeline, the drug maker said.
As per 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 ₹1,657.35 apiece on BSE.
Published on June 18, 2025
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