USFDA inspection: With OAI observations at Sun Pharma

An OAI classification is a serious designation after the USFDA inspection, indicating significant deficiencies in a manufacturing facility's

The Health Master

April 28, 2024

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USFDA Inspection audit — USFDA Inspection

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Last Updated on May 8, 2024 by The Health Master

USFDA inspection

Recently USFDA inspection has been conducted by the US Food and Drug Administration (USFDA) at Sun Pharmaceutical Industries Limited (Sun Pharma) for its Dadra plant and assigned it an Official Action Indicated (OAI) classification, raising concerns about potential drug quality and safety issues.

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What is an OAI Classification?

An OAI classification is a serious designation after the USFDA inspection, indicating significant deficiencies in a manufacturing facility’s compliance with Good Manufacturing Practices (GMP) regulations.

This signifies that the USFDA has identified observations at the plant and deems the company’s response inadequate.

Facilities with OAI designations typically face follow-up inspections and potential regulatory actions, including import alerts or even production stoppages, until compliance is achieved.

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Specific Observations at Sun Pharma’s Dadra Plant:

The USFDA report outlined six key observations at the Dadra plant, highlighting potential risks to drug quality and patient safety:

Incomplete Investigations: The plant’s investigation procedures for Out-of-Specification (OOS) results, which occur when drug samples fail quality tests, were found to be inadequate in determining the root cause of such failures, particularly for products sold in the US market.
Equipment Maintenance Issues: Practices for cleaning and maintaining equipment and utensils were deemed insufficient to prevent contamination that could affect drug product safety, identity, strength, and purity.
Quality Unit Oversight Lapses: The report identified a lack of proper oversight by the Quality Unit regarding the issuance, handling, retrieval, and reconciliation of crucial Good Manufacturing Practices (GMP) documents used in drug production at the facility.
Deficient Complaint Handling Procedures: The plant’s procedures for managing written and oral complaints related to drug products were found to be either poorly documented or not followed effectively.
Missing Field Alert Submissions: The company failed to submit a required Field Alert notification to the USFDA regarding product quality complaints. Field Alerts are crucial for informing healthcare providers and patients about potential safety risks associated with specific drug products.
Inadequate Reserve Sample Examination: The plant did not perform the necessary annual visual inspections of reserve samples from drug product batches to identify any signs of deterioration.

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Potential Impact on Sun Pharma and US Consumers:

This recent OAI classification for Sun Pharma’s Dadra plant adds to the company’s existing regulatory challenges faced at its Halol and Mohali facilities.

These issues could potentially lead to disruptions in the supply of Sun Pharma’s generic drugs in the US market.

This, in turn, could impact patient access to affordable medications and strain the US healthcare system.

Looking Ahead:

Sun Pharma has committed to working with the USFDA to address the observations and achieve full compliance.

The company’s swift and effective corrective actions will be crucial in regaining the USFDA’s confidence and ensuring the continued availability of its generic drugs for patients in the US.

Note: This article is for informational purposes only and does not constitute medical advice. Always consult with a qualified healthcare professional for any questions or concerns you may have regarding your medications.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.