US FDA makes 3 observations after inspecting Dr Reddy’s UK plant
US FDA audits Dr Reddy’s API Mirfield plant in UK, issues FDA Form 483 with three observations
New Delhi: Pharmaceutical company Dr Reddy’s Laboratories on Friday said the US health regulator has made three observations after inspecting its UK facility.
The audit of API Mirfield plant in the UK by the US Food and Drug Administration (FDA) was completed on Friday, Dr Reddy’s said in a regulatory filing to stock exchanges.
“We have been issued a Form 483 with three observations, which we are addressing,” it added.
As per the US FDA, “FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related acts.”
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