Receives five observations under Form 483
Lupin announced that the US FDA inspected company's Nagpur Unit-2 injectable manufacturing facility from 17 October 2022 to 29 October 2022. The inspection was a Pre-Approval Inspection of the injectable facility. The inspection closed with issuance of a Form-483 with five observations.The company said that it is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the U.S.
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