USFDA inspection: Lupin gets 10 observations for Pithampur facility
Mumbai: Lupin has recently announced that US Food and Drug Administration (U.S. FDA) has concluded an inspection with ten observations at the company's Pithampur Unit-2 manufacturing facility.
The inspection was conducted from March 21 to March 29, 2023.
"The inspection closed with issuance of a Form-483 with ten observations. We are addressing the observations comprehensively and will work with the U.S. FDA to resolve these issues at the earliest. We uphold quality and compliance with utmost importance across all our facilities," the company stated in a BSE filing.
An 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 judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Medical Dialogues team had earlier reported that Lupin Limited had successfully completed the inspection carried out by the UK Medicines and Healthcare products Regulatory Agency (UK MHRA) at its Pithampur facilities in India.
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