GUFIC BIO : USFDA ISSUES 3 OBSERVATIONS AT INDORE FACILITY

• USFDA conducted a Pre-Approval Inspection at the company's manufacturing facility at Plot no. 48, Smart Industrial Park, Near Natrip, Pithampur, District Dhar, Indore, Madhya Pradesh • Inspection carried out from October 15, 2026 to October 23, 2026 • Company received 3 observations in Form FDA 483 upon conclusion of the inspection • Company to work closely with USFDA and address the observations comprehensively within the stipulated timeframe

Gufic Biosciences Ltd

Open attachment

← Back to feed