Emcure Pharmaceuticals Ltd. on Wednesday said the US health regulator has issued two observations after inspecting its Pune-based active pharmaceutical ingredients manufacturing facility.
The US Food and Drug Administration conducted a current Good Manufacturing Practice inspection of the plant from February 19-25 this year, the drug firm said in a regulatory filing.
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At the conclusion of the inspection, the company received two observations in Form 483, it added.
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"We are addressing the observations comprehensively and will respond to the USFDA within the stipulated time frame, Emcure Pharmaceuticals 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 Act and related Acts.
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