Last Updated on December 31, 2023 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.
USFDA issues Form 483 with 9 observations to Panacea: Baddi
USFDA issues Form 483 with 9 observation to Dr Reddy’s laboratories: Hyderabad
USFDA issued EIR to InvaGen Pharma of Cipla
USFDA issues Form 483 with one observation to Aurobindo Unit IV: Andhra Pradesh
USFDA issues Form 483 with one observation to Aurobindo: Andhra Pradesh
USFDA Approval: USFDA Approval granted for Apremilast Tablets
Drug recall: Sun Pharma subsidiary recalls this Anti-depression drug
Pharmaceutical Quality: Key Amendments in Revised Schedule M
Drug recall: This Nasal Spray recalled due to Microbial Contamination
Fake drug manufacturing factory busted: Dehradun
Reactor blasts in Pharmaceutical Company: Hyderabad
USFDA issues Form 483 with 9 observation to Panacea: Baddi
Govt Job: For the post of Assistant Controller Drugs under Drugs & Food Control
Drug recall: 7,248 bottles of Oxybutynin Chloride tablets recalled
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
