Last Updated on December 31, 2023 by The Health Master
Form 483
In a recent development, the US Food and Drug Administration (USFDA) has issued Form 483 after conducting an evaluation of the biologics manufacturing plant operated by Panacea Biotec Pharma Limited in Baddi, Himachal Pradesh.
During this inspection, the regulatory body issued a Form 483, highlighting nine observations.
This article delves into the details of the inspection, the implications of Form 483, and how companies like Panacea Biotec can strategically navigate such situations.
Panacea Biotec’s Response and Commitment
Inspection Timeline:
The USFDA conducted the inspection of Panacea Biotec Pharma Limited’s subsidiary from October 3 to 12. This thorough evaluation underscores the regulatory body’s dedication to maintaining pharmaceutical industry standards.
Company Assurance and Pledge for Remediation:
Panacea Biotec promptly addressed the issued Form 483 observations, demonstrating their commitment to regulatory compliance.
The company is resolute in rectifying the identified concerns within the stipulated time frame.
Understanding Form 483: A Critical Assessment
- Form 483 and its Significance: The issuance of a Form 483 by the USFDA signifies the identification of objectionable practices within a facility undergoing inspection. This regulatory instrument is crucial in ensuring compliance with quality standards and practices.
- Official Action Indicated (OAI) vs. Voluntary Action Indicated (VAI):
- OAI Classification: If the observed lapses are of a severe nature, the facility may be classified as “Official Action Indicated.” This designation restricts the company from filing or exporting any drugs from the premises.
- VAI Classification: In cases of less severe lapses, the USFDA may issue a “Voluntary Action Indicated” classification. This does not impede the company’s ability to file or export drugs from the unit.
Disclaimer: The information provided in this article is for informational purposes only and does not constitute legal or professional advice. It is recommended to consult with a qualified regulatory affairs consultant or legal expert for specific guidance on USFDA compliance.
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 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 gives positive Inspection Report to Lupin: Nagpur
USFDA’s New Inspection Approach for India’s Pharmaceutical Industry
Govt Job: For the post of Assistant Controller Drugs under Drugs & Food Control
USFDA tentative approval granted for Apalutamide tablets
Drug recall: 7,248 bottles of Oxybutynin Chloride tablets recalled
Major Bust: Illegal Alprazolam Factories Unearthed in Pune
Crackdown on Illegal Drug Factory in Ambala Cantt: FDA Haryana Takes Swift Action
Jan Vishwas Act: Transforming Penalties for Drug Advertising Offenses
USFDA approval granted for this inflammatory bowel disease drug
USFDA issues Form 483 with 9 observation to Dr Reddy’s laboratories: Hyderabad
Regulatory Changes: Relief for Class C and D Medical Device in India
Govt Job: Unlocking Opportunities for CDSCO Recruitment 2023
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:
