USFDA23 Oct 2026, 04:23 pm
Gland Pharma: USFDA Inspection Concluded with 4 Observations
AI Summary
Gland Pharma Limited announced the conclusion of an unannounced USFDA inspection at its Dundigal formulation facility, which took place from October 12-23, 2026. The inspection resulted in four Form 483 Observations, which the company described as procedural. Gland Pharma will submit corrective and preventive actions to the USFDA within the stipulated period. The company stated that the observations are neither repeated nor related to data integrity. Further details are provided in Annexure A.
Key Highlights
- USFDA inspection concluded at Dundigal facility.
- Four procedural Form 483 observations were issued.
- Observations are not repeated and not data integrity related.
- Company will submit corrective actions to USFDA.
Price Impact
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