Last Updated on December 31, 2023 by The Health Master
Lupin, on July 12 has informed that United States Food and Drug Administration (USFDA) inspected its Nagpur Oral Solid Dosage facility from July 3 to July 11, 2023.
The inspection closed with issuance of a Form 483 with two observations.
“We are confident of addressing the observations raised, and will work with the USFDA to resolve them at the earliest,” Lupin said.
“We uphold quality and compliance issues with utmost importance and remain committed to be compliant with CGMP quality standards across all our facilities,” the company added.
On July 11, the company received the establishment inspection report (EIR) from USFDA for its Pithampur Unit-2 manufacturing facility that manufactures oral solids and ophthalmic dosage forms.
The EIR was issued post the last inspection of the facility conducted from March 21 to March 29, 2023.
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).
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