Industry

USFDA issues Form 483 with 2 observations to Gland Pharma: Hyderabad

August 27, 2023

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Last Updated on October 9, 2024 by The Health Master

USFDA issues Form 483

The U.S. Food and Drug Administration (USFDA) recently completed a pre-market inspection of Gland Pharma’s Pashamylaram facility in Hyderabad. The USFDA also issued Form 483 with two observations.

This article delves into the details of the inspection, the observations made, and Gland Pharma’s response to ensure compliance with quality standards.

Inspection Details and Observations:

The inspection, carried out by the Office of Medical Device and Radiological Health Operations of the USFDA, covered the assessment of Gland Pharma’s adherence to the quality system and current good manufacturing practice regulations for medical devices, as outlined in 21 CFR Part 820.

The inspection took place over a four-day period, from August 23 to August 26.

During the inspection, Gland Pharma’s Pashamylaram facility was evaluated, with a particular focus on its production of generic injectables.

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The company had filed an Abbreviated New Drug Application (ANDA) for a specific product intended to be manufactured using a PEN (Pre-filled Syringe) device at the mentioned facility.

The outcome of the inspection resulted in the issuance of Form 483, a document issued by the USFDA to notify a company of any deviations or observations found during inspections. Gland Pharma received two observations on this Form 483.

Importantly, it’s worth noting that there were no observations related to data integrity, indicating that the company’s data management processes were in accordance with regulatory standards.

Gland Pharma’s Response on Form 483:

In response to the observations highlighted in Form 483, Gland Pharma has expressed its full commitment to addressing the identified issues promptly and effectively.

The company recognizes the importance of compliance with regulatory requirements to ensure the safety and efficacy of its medical products.

Gland Pharma has outlined its plan to meticulously address each observation mentioned in Form 483.

The company is dedicated to rectifying any deviations from the established quality standards and implementing the necessary corrective actions.

Furthermore, Gland Pharma has assured its stakeholders that it will submit a comprehensive and timely response to the USFDA, demonstrating its dedication to resolving the observations within the stipulated timeframe.

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Conclusion:

The recent pre-market inspection of Gland Pharma’s Pashamylaram facility by the USFDA underscores the significance of maintaining high-quality manufacturing practices in the pharmaceutical industry.

With a commitment to rectify the observations made during the inspection, Gland Pharma aims to uphold its reputation as a reliable provider of medical products and ensure the continued safety and efficacy of its offerings.

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