Last Updated on March 19, 2025 by The Health Master
USFDA inspection
In a significant boost to its global standing, Mumbai-based JB Chemicals and Pharmaceuticals has announced that its Active Pharmaceutical Ingredient (API) manufacturing facility, D9, located in Panoli, Gujarat, has successfully concluded a rigorous inspection by the U.S. Food and Drug Administration (USFDA inspection).
The inspection, held from March 10th to March 13th, 2025, resulted in a resounding “No Observations” outcome, signifying the facility’s adherence to the highest quality and compliance standards.
This achievement is particularly noteworthy in the competitive pharmaceutical landscape, where USFDA approvals are crucial for market access and credibility.
Zero Deviations:
The absence of a Form 483, the official document issued after USFDA inspection when investigators identify potential violations of the Food, Drug, and Cosmetic (FD&C) Act, underscores the facility’s exemplary performance.
This “No Observations” outcome is a clear indicator that JB Chemicals‘ Panoli facility met all the stringent requirements during the inspection.
Achieving this level of compliance is a testament to the company’s commitment to robust quality control and operational excellence.
This news is a major win for the company and is likely to positively affect its stock price.
Commitment to Excellence
The company emphasized its focus on embedding a strong quality culture throughout the organization and continuously investing in systems, processes, and employee training.
This proactive approach ensures that the company maintains the highest standards of quality and compliance across all its markets, including the highly regulated U.S. market.
JB Chemicals:
Founded in 1976, JB Chemicals and Pharmaceuticals has grown into a significant player in the global pharmaceutical industry.
Headquartered in Mumbai, India, the company generates a substantial portion of its revenue from the Indian market.
It also has a strong presence in Russia and South Africa, which it considers its other key home markets.
Furthermore, JB Chemicals exports its finished formulations to over 40 countries, including the United States.
Q. What is a USFDA Form 483?
A USFDA Form 483 is issued to a company’s management at the conclusion of an inspection when investigators have observed conditions that may violate the FD&C Act.
Q. What does “No Observations” mean?
“No observations” means that the USFDA inspectors did not identify any significant violations or deviations from regulatory requirements during the inspection.
Q. How many manufacturing facilities does JB Chemicals have?
JB Chemicals has eight state-of-the-art manufacturing facilities in India.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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