Dr Reddy's gets 3 observations from USFDA for US-based API plant
City-based Dr Reddy's Laboratories (DRL) on Wednesday said that the US Food and Drug Administration (USFDA) has issued a Form 483 with three observations after inspecting its manufacturing facility in Middleburg, New York.
Dr Reddy’s gets 3 observations from USFDA for US-based API plant
Hyderabad: City-based Dr Reddy's Laboratories (DRL) on Wednesday said that the US Food and Drug Administration (USFDA) has issued a Form 483 with three observations after inspecting its manufacturing facility in Middleburg, New York.
The global drug major further stated that the US health regulator has completed the audit of the company's active pharmaceutical ingredients (API) manufacturing plant at Middleburg, New York.
Dr Reddy's Lab in a communique to the BSE said: "We have been issued a Form 483 with 3 (three) observations. We will address them comprehensively within the stipulated timeline. Currently, we do not have any sales from this plant," it added.
As per the USFDA, Form 483 is issued to firm management at the conclusion of an inspection when investigators have observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related acts.
