Lupin gets 6 USFDA observations for Somerset facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-05-20 06:33 GMT | Update On 2024-06-20 18:54 GMT
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Mumbai: Lupin has announced that the US Food and Drug Administration (U.S. FDA) has concluded a Pre Approval Inspection with an issuance of a Form-483 with six observations at the Company’s Somerset, New Jersey manufacturing facility.
The inspection was conducted from May 7, 2024 to May 17, 2024.
"We are addressing the observations comprehensively and will respond to the U.S. FDA within the stipulated timeframe," the Company stated.
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