Lupin Limited has announced the conclusion of an inspection by the U.S. Food and Drug Administration (FDA) at its manufacturing facility located in Ankleshwar, India. The inspection period spanned from March 02, 2026, to March 07, 2026. The facility closed the inspection with the issuance of a Form-483, which included two observations. The company has affirmed its commitment to immediately address these observations and respond to the FDA within the mandated timeline.
Conclusion of US FDA Inspection
Lupin Limited formally disclosed the completion of an inspection conducted by the U.S. Food and Drug Administration (FDA) at its key manufacturing site in Ankleshwar, India. The regulatory assessment took place over six days, commencing on March 02, 2026, and concluding on March 07, 2026.
Form-483 Issued with Two Observations
The inspection process concluded with the issuance of a Form-483 to the company. This document outlined a total of two specific observations noted by the inspecting authority. Management stated that they are fully prepared to address these points raised during the review.
Commitment to Compliance
Lupin emphasized its ongoing dedication to maintaining compliance with Current Good Manufacturing Practice (CGMP) standards across all its global facilities. The Company Secretary & Compliance Officer confirmed that the requisite response to the U.S. FDA addressing the observations will be submitted within the stipulated regulatory timeframe.
Source: BSE
