Dr Reddy's gets seven observations from USFDA for Andhra plant
has received a
Form 483
with seven observations from the US health regulator for its Srikakulam-based plant in
Andhra Pradesh
, according to a regulatory filing.
The US Food and Drug Administration (
USFDA
) conducted the GMP and a Pre-Approval Inspection (PAI) at the formulations manufacturing facility from July 10 to 18, 2025, the Hyderabad-based drug major said in the filing.
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"We have been issued a Form 483 with seven observations, which we will address within the stipulated timeline," it added.
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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.
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