Key Event Details
The United States Food and Drug Administration (USFDA) conducted a Pre-Approval Inspection at the company's manufacturing facility located at Plot no. 48, Smart Industrial Park, Near Natrip, Pithampur, District Dhar – 454775, Indore, Madhya Pradesh.
Inspection Timeline
The inspection took place from October 15, 2026 to October 23, 2026.
Inspection Outcome
Upon conclusion of the inspection, the company received 3 (three) observations in Form FDA 483.
Company Response
The company will work closely with the USFDA and remains committed to addressing the observations comprehensively within the stipulated timeframe.