Last Updated on March 18, 2025 by The Health Master
USFDA inspection
The US Food and Drug Administration inspection (USFDA inspection) concluded successfully at the manufacturing facility of JB Chemicals & Pharmaceuticals Limited situated at Panoli, Gujarat.
The inspection was conducted between March 3rd and 7th, 2025 and there found no observations at the facility which concluded that the company has done good quality assurance efforts.
This positive inspection will directly impacts the export compliance of the company and increase position of the company in the market.
No Form 483 Issued
The USFDA’s “no observations” result shows that the company JB Chemicals’ is strictly complying the regulatory standards.
If a Form 483 is issued, which is issued when the inspectors observes some critical violations of the Food, Drug, and Cosmetic (FD&C) Act, underscores the quality control system of the facility.
This news is particularly relevant for those seeking information on USFDA inspection success rates and the implications for pharma manufacturing quality.
“We wish to inform the exchange that the Company’s formulations manufacturing facility- T20 located at Plot No. 4, GIDC, Panoli, Gujarat was inspected by the USFDA,” JB Chemicals stated in their BSE filing.
“The said USFDA inspection has been successfully completed by the USFDA with “No Observations” and thus NO Form 483 was issued.”
JB Chemicals
Established in 1976, JB Chemicals & Pharmaceuticals has evolved into a prominent player in the global pharmaceutical industry.
Beyond its strong presence in India, which contributes significantly to its revenue, the company has established strong footholds in Russia and South Africa. In India, six of its brands feature among the top 300 Indian Pharmaceutical Market (IPM) brands.
The company exports finished formulations to over 40 countries, including the United States, demonstrating its global reach.
In addition to branded generic formulations, JB Chemicals specializes in medicated lozenges.
With eight state-of-the-art manufacturing facilities in India, including a dedicated lozenge manufacturing plant, the company holds certifications from leading regulators worldwide.
This broad reach and certifications are important for those looking for information about global pharmaceutical supply chains and pharmaceutical manufacturing certifications.
Q. What is a USFDA Form 483?
A. A Form 483 is issued by the USFDA to a company’s management at the conclusion of an inspection when investigators have observed conditions that may constitute violations of the Food, Drug, and Cosmetic Act.
Q. What does “no observations” mean in a USFDA inspection?
A. It means that the USFDA investigators did not find any significant deviations from regulatory requirements during the inspection.
Q. Why is a successful USFDA inspection important for a pharmaceutical company?
A. It demonstrates the company’s commitment to quality and compliance, which is essential for maintaining market access in the United States and other regulated markets.
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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