Gland Pharma Ltd announced on Tuesday, 25 February, that the U.S. Food and Drug Administration (USFDA) has completed a key inspection of its Andhra Pradesh facility.
In a regulatory filing, the company stated that the USFDA conducted a pre-approval inspection (PAI) for sterile APIs at its facility in Jawaharlal Nehru Pharmacy City (JNPC), Visakhapatnam, between 19 February and 25 February 2025.
Following the inspection, the regulatory body issued three Form 483 observations, which Gland Pharma described as procedural. The company clarified that these observations are not recurring from past inspections and do not raise concerns regarding data integrity.
Gland Pharma further assured us that it would submit corrective and preventive action plans to the USFDA within the required timeframe.
Under U.S. regulations, the FDA can approve a new drug application (NDA) or an abbreviated new drug application (ANDA) only if the manufacturing, processing, packaging, and testing facilities meet specified standards.
A Form 483 is a document issued by USFDA inspectors outlining any observations made during the inspection. It does not represent a final regulatory decision. Companies receiving a Form 483 are required to submit their response within 15 days, detailing corrective measures to address the observations.
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