Monday 28 August 2023

USFDA issues 483 observations to Gland Pharma

Gland Pharma Commits to Address Observations from USFDA Inspection

Hyderabad-based pharmaceutical company Gland Pharma recently underwent a pre-market inspection conducted by the U.S. Food and Drug Administration (USFDA) at its Pashamylaram facility. The inspection, which took place from August 23 to August 26, focused on evaluating the company's adherence to quality system and good manufacturing practices for medical devices.

The USFDA inspection resulted in the issuance of Form 483, a document that outlines any deviations or observations identified during the inspection process. Gland Pharma received two observations on the Form 483, highlighting specific areas that require attention. However, it is worth noting that these observations did not pertain to data integrity, indicating that the company's data management processes met regulatory standards.

In response to the observations, Gland Pharma has expressed a strong commitment to promptly and effectively addressing the identified issues. The company recognizes the significance of adhering to regulatory requirements to ensure the safety and effectiveness of its medical products. Gland Pharma has outlined a comprehensive plan to meticulously address each observation mentioned in the Form 483, aiming to rectify any deviations from established quality standards.

Furthermore, Gland Pharma has assured its stakeholders that it will submit a thorough and timely response to the USFDA. This commitment reflects the company's dedication to resolving the observations within the specified timeframe.

The recent inspection by the USFDA highlights the importance of maintaining high-quality manufacturing practices in the pharmaceutical industry. Gland Pharma is dedicated to upholding its reputation as a dependable provider of medical products and ensuring the continued safety and efficacy of its offerings.

Disclaimer: The information presented in this article is derived from a news source and has been paraphrased using an AI language model.

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