Emcure Pharma Gets Form 483 With Two Observations For API Plant From USFDA
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.
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.
At the conclusion of the inspection, the company received two observations in Form 483, it added.
"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.
