Last Updated on October 9, 2024 by The Health Master
Form 483
Gland Pharma, a prominent player in the global injectable pharmaceutical market, has disclosed that its Dundigal facility underwent an unannounced inspection by the stringent United States Food and Drug Administration (USFDA) and got Form 483 with two observations.
The inspection, conducted between July 22 and July 25, 2024, focused on evaluating the facility’s adherence to Good Manufacturing Practices (GMP) standards.
Minor Procedural Issues Identified
While the news of an USFDA inspection can often trigger concerns, Gland Pharma has clarified that the outcome was relatively benign.
The company received two observations on Form 483, which are typically considered procedural in nature rather than critical violations.
These observations highlight areas where the facility’s operations might require improvement to align fully with USFDA regulations.
The pharmaceutical giant has assured stakeholders that it will promptly address the observations by submitting a comprehensive corrective and preventive action (CAPA) plan to the USFDA within the stipulated timeframe.
Notably, the company emphasized that the issues raised are neither recurring problems nor related to data integrity, a critical aspect of pharmaceutical manufacturing.
Gland Pharma: A Global Injectable Leader
Established in 1978, Gland Pharma has evolved from a modest contract manufacturer into a global pharmaceutical powerhouse.
With a strong presence in over 60 countries, including the United States, Europe, and Australia, the company is a key supplier of injectable medications.
Its extensive product portfolio encompasses a wide range of injectable formulations, catering to diverse therapeutic areas such as oncology, ophthalmology, and general medicine.
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