Last Updated on December 22, 2024 by The Health Master
OAI Status
Biocon Ltd recently announced a significant development regarding issuance of OAI status to its subsidiary, Biocon Sdn Bhd, located in Johor, Malaysia
The United States Food and Drug Administration (USFDA) has classified the manufacturing facility’s status as ‘official action indicated’ (OAI) after a thorough inspection.
This classification carries implications for pending product approvals and supplements, potentially causing delays and withholdings, as stated in Biocon Ltd’s regulatory filing.
Understanding the OAI Status:
The ‘official action indicated’ status (OAI Status), designated by the USFDA, signifies a critical regulatory stance.
It implies that the agency may temporarily withhold approval for any pending product applications or supplements from the facility until outstanding observations related to non-compliance with established manufacturing norms are satisfactorily addressed.
Insights from Biocon Spokesperson:
A spokesperson from Biocon provided insights into the situation, emphasizing that Biocon Sdn Bhd is a subsidiary of Biocon Biologics Ltd, and the USFDA’s decision stems from the comprehensive cGMP (current Good Manufacturing Practice) inspection conducted in July 2023 at the insulins manufacturing facility in Johor, Malaysia.
The spokesperson further elaborated on the USFDA’s determination of the inspection classification as ‘OAI’, highlighting the potential ramifications.
They noted that this status could lead to delays and withholding of pending product approvals or supplements from the facility.
Corrective Measures:
In response to the observations made during the July inspection, Biocon has taken proactive steps.
The company has submitted a comprehensive Corrective and Preventive Action (CAPA) plan to the USFDA.
Must read: NSQ Drug: Route cause analysis and CAPA
This plan outlines the measures Biocon intends to implement to rectify the non-compliance issues, demonstrating their commitment to ensuring adherence to the established manufacturing norms.
Biocon expresses confidence in their ability to meet the outlined action points within the stipulated timeframe.
They are committed to working closely with the USFDA to address any outstanding concerns and to expedite the resolution process.
Assessing Impact and Moving Forward:
Biocon maintains a positive outlook, asserting that they do not anticipate a significant disruption in the manufacturing and distribution of their commercial products for the US market.
This proactive approach is in line with their commitment to maintaining the highest quality standards and compliance with regulatory requirements.
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.
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