Last Updated on December 21, 2024 by The Health Master
Form 483
Aurobindo Pharma Ltd. recently announced the successful completion of a US Food and Drug Administration (USFDA) inspection at its subsidiary, Apitoria Pharma Private Ltd.’s Unit-V with issuance of Form 483.
This facility plays a crucial role in the production of active pharmaceutical ingredients (APIs), the core components of medications.
The inspection, which took place between December 9th and 17th, 2024, at the Pashamylaram Village facility in Telangana, India, concluded with only two procedural observations on Form 483.
This outcome is generally considered positive, indicating a well-maintained and compliant facility.
Details of the USFDA Inspection
The USFDA’s rigorous inspection process aims to ensure that pharmaceutical manufacturing facilities adhere to strict quality standards and regulations.
These inspections are critical for maintaining the safety and efficacy of drugs sold in the United States.
The inspection of Apitoria Pharma’s Unit-V focused on various aspects of the manufacturing process, including:
- Manufacturing processes: Ensuring adherence to established procedures and protocols.
- Quality control systems: Evaluating the effectiveness of quality checks and testing.
- Documentation and record-keeping: Verifying accurate and complete records of all manufacturing activities.
- Facility maintenance and hygiene: Assessing the overall condition and cleanliness of the facility.
Procedural Observations on Form 483 and Next Steps
The fact that the inspection resulted in only two procedural observations on Form 483 is a positive sign.
“Procedural” in this context typically refers to minor deviations from established documentation or standard operating procedures, rather than significant issues with product quality or manufacturing processes.
Aurobindo Pharma has stated its commitment to addressing these observations on Form 483 within the required timeframe.
This involves submitting a detailed response to the USFDA outlining corrective actions and preventive measures to ensure future compliance.
Impact on Aurobindo Pharma and the Pharmaceutical Industry
Successful USFDA inspections are crucial for pharmaceutical companies like Aurobindo Pharma, as they ensure continued access to the lucrative US market.
This positive outcome for Apitoria’s Unit-V reinforces the company’s commitment to quality and compliance.
It also contributes to maintaining confidence in the Indian pharmaceutical industry’s ability to meet international regulatory standards.
By focusing on clear, concise language, providing context, and incorporating relevant keywords, this rewritten article offers a more comprehensive and engaging overview of the news while also being optimized for search engines.
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What is an API?
An API (Active Pharmaceutical Ingredient) is the biologically active component of a drug product.
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What does an USFDA inspection involve?
USFDA inspections involve a comprehensive review of a manufacturing facility’s processes, systems, and documentation to ensure compliance with regulations.
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What is the significance of procedural observations?
Procedural observations are typically minor deviations from established procedures and are usually easily addressed.
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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