US FDA issues Form-483 with eight observations to Lupin’s drug, API production facilities in Mandideep plant
The US Food and Drug Administration (FDA) had inspected the Mandideep Unit-1 facility in Madhya Pradesh from 14th November, 2022, to 23rd November, 2022
Lupin yesterday said the US health regulator has issued Form-483 with eight observations each for product and raw material production centres at its Mandideep-based manufacturing facility.
The US Food and Drug Administration (FDA) had inspected the Mandideep Unit-1 facility in Madhya Pradesh from 14th November, 2022, to 23rd November, 2022, the drug maker said in a regulatory filing.
“The inspection of the facility closed with issuance of a Form-483 with eight observations each for the drug product facility and Active Pharmaceutical Ingredient (API) facility at the site,” it added.
The company is committed to address the observations, and will work with the US health regulator to resolve the issues at the earliest, Lupin said.
On 30th October, the drugmaker announced that the US health regulator has issued Form-483 with five observations following a pre-approval inspection of its Unit-2 injectable manufacturing facility at Nagpur.
Edits by EP News Bureau
- Advertisement -
