USFDA23 Oct 2026, 08:50 pm
Gufic Biosciences: USFDA Inspection Yields 3 Observations
AI Summary
Gufic Biosciences Ltd announced that the United States Food and Drug Administration (USFDA) conducted a Pre-Approval Inspection at its manufacturing facility in Indore, Madhya Pradesh, from October 15 to October 23, 2026. Following the inspection, the company received 3 observations in Form FDA 483. Gufic Biosciences has stated its commitment to working closely with the USFDA and addressing these observations comprehensively within the stipulated timeframe.
Key Highlights
- USFDA conducted a pre-approval inspection at the Indore facility.
- The inspection took place from October 15 to October 23, 2026.
- Company received 3 observations in Form FDA 483.
- Gufic Biosciences committed to addressing observations.
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