Lupin Limited Gets 3 Observations After USFDA Inspection of Somerset Facility
New Delhi: Lupin Limited has informed that the United States Food and Drug Administration (USFDA) has concluded an inspection at its manufacturing facility in Somerset, New Jersey, USA.
The inspection was conducted from April 13, 2026 to April 17, 2026 and closed with the issuance of a Form-483 with three observations.
The inspection was carried out by the USFDA as part of its regulatory oversight at Lupin’s manufacturing site in the United States. At the conclusion of the inspection, the regulator issued a Form 483 listing three observations, indicating areas where corrective actions are required.
Lupin stated that it will respond to the observations within the prescribed timeline and reiterated its commitment to maintaining compliance with current Good Manufacturing Practices (cGMP) across all its manufacturing facilities.
"We will address the observations and respond to the U.S. FDA within the stipulated timeframe. We are committed to be compliant with CGMP standards across all our facilities." Lupin Limited added.
