Last Updated on July 17, 2025 by The Health Master
USFDA inspection
Hyderabad, India— The U.S. Food and Drug Administration inspection (USFDA inspection) was recently completed at Natco Pharma at its Kothur, Hyderabad facility.
The USFDA inspection, which took place from June 9th to June 19th, 2025, ended with the issuance of a Form 483 with seven observations.
This is a routine in the highly regulated pharmaceutical industry, it underscores the continuous scrutiny on drug manufacturers to uphold the highest standards of quality and compliance related to the drugs manufactured by them.
Understanding the USFDA Form 483
USFDA Form 483 is issued to a company’s management at the end of an inspection when inspectors have noted observations with respect to conditions or practices adopted by the company; it also includes violations of the Food, Drug, and Cosmetic (FD&C) Act and related regulations.
These observations can vary from minor procedural lapses to more significant concerns regarding manufacturing processes and quality control.
Natco Pharma’s response
In a regulatory filing, the company expressed that they are able to resolve the observations within the stipulated time.
Natco Pharma will now review each of the seven observations and prepare a comprehensive response.
Q: What is a USFDA Form 483?
A. Form 483 is issued by a USFDA officer to a company after the completion of the findings the team has observed as per the Food, Drug, and Cosmetic Act and related acts.
Q: What is cGMP compliance?
A. cGMP (Current Good Manufacturing Practices) refers to the regulations enforced by the USFDA to ensure the quality and efficacy of the pharmaceutical products manufactured at the facility.
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