Last Updated on March 13, 2025 by The Health Master
Form 483 by USFDA
The United States Food and Drug Administration (USFDA) successfully completed a scheduled inspection at Alembic Pharmaceuticals for its facility in Vadodara, Gujarat, and issued Form 483.
The USFDA inspection, conducted from March 3rd to March 7th, 2025, issued Form 483 with one observation, i.e., a procedural observation.
This development has sparked interest among investors and industry analysts, particularly those focusing on pharmaceutical regulatory compliance, generic drug approvals, and bioequivalence study costs.
What is USFDA Form 483?
USFDA Form 483 is a form issued by USFDA to a pharma company after the completion of an inspection at that facility, mentioning the observations in it.
It contains the observations detected by the USFDA during inspection under the Food, Drug, and Cosmetic (FD&C) Act and related regulations.
In the present case, Alembic received only one procedural observation, which suggests a relatively minor finding.
This is important for investors tracking pharmaceutical stock analysis and USFDA inspection outcomes.
Quality and Compliance by Alembic
Alembic Pharmaceuticals, a publicly listed, vertically integrated research and development pharmaceutical company headquartered in India, has stated its commitment to addressing the observation.
“The company will provide a comprehensive response to the USFDA for the observation within the stipulated period.
The company said that it is it’s commitment to maintain the high quality standards as well as at the facility as per rules and regulations laid down by USFDA.
This proactive approach of the company is very important for maintaining the reputation of the company.
Q: What is Form 483 issued by USFDA?
A: USFDA Form 483 is a form issued by USFDA to a pharma company after the completion of inspection at that facility mentioning the observations in it.
Q: What does procedural observation mean?
A: It indicates that the USFDA found an observation that is a minor deviation from its procedures during the inspection. It is generally less severe than multiple or significant observations.
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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