Last Updated on July 8, 2025 by The Health Master
USFDA inspection
Recent developments at Sun Pharma‘s Halol facility in Gujarat, India, highlight the United States Food and Drug Administration inspection (USFDA inspection) at the plant regarding pharmaceutical quality assurance and USFDA compliance.
8 Observations
From June 2nd to June 13th, 2025, a USFDA inspection was conducted at Sun Pharma’s significant Halol manufacturing plant.
The outcome, as disclosed in a regulatory filing by the company, was the issuance of a Form 483 with eight observations.
For those unfamiliar with the regulatory jargon, a Form 483 is essentially a list of conditions or practices observed by the USFDA investigator that, in their judgment, may constitute violations of the Food, Drug, and Cosmetic Act and related acts.
These observations indicate potential deviations from established procedural guidelines or documentation requirements, necessitating immediate corrective action from the manufacturer.
Sun Pharma’s Response
In the wake of the latest Form 483, Sun Pharma has affirmed its commitment to addressing the concerns raised by the USFDA.
The company stated it would “respond to the observations and take all necessary steps to address the concerns raised by the regulator.”
This commitment is standard procedure, but the speed and efficacy of their corrective actions will be critical in determining the future status of the Halol plant.
Looking Ahead
Sun Pharma will need to submit a comprehensive response to the USFDA detailing their plans for corrective and preventive actions (CAPA). This typically involves:
- Root Cause Analysis: Identifying the underlying reasons for the observed deviations.
- Corrective Actions: Implementing immediate fixes for the identified problems.
- Preventive Actions: Establishing systems and processes to prevent recurrence of similar issues.
- Evidence of Effectiveness: Demonstrating that the implemented changes are working.
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 does an “import alert” mean for the pharmaceutical industry?
An import alert means that drugs manufactured at the particular facility are generally not allowed to enter into the United States.
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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