Last Updated on July 21, 2025 by The Health Master
USFDA inspection
Mumbai, India— Unichem Laboratories Ltd., a Mumbai-based pharmaceutical company, recently announced the completion of a United States Food and Drug Administration inspection (USFDA inspection) at its Active Pharmaceutical Ingredient (API) manufacturing facility in Roha, Maharashtra.
The inspection was conducted from June 16th to June 20th, 2025, with three observations on Form 483 from the USFDA.
Understanding USFDA Observations:
When the USFDA conducts an inspection in a pharmaceutical facility, it’s a thorough review of a facility’s compliance with the Good Manufacturing Practices (GMP).
Observations are given on Form 483 after the completion of the USFDA inspection.
Unichem’s official statement clarified that the three observations were primarily related to “procedural changes.”
The company emphasized that none of these observations were related to data integrity issues.
The company has a stipulated 15-day timeframe to provide a response to the USFDA, mentioning its corrective and preventive actions (CAPAs).
What Happens Next?
Unichem’s next step is to submit a detailed response to the USFDA within the 15-day timeframe.
This response will outline how they plan to address each observation, including specific corrective actions.
The USFDA will then review Unichem’s response.
Depending on the nature of the observations and the adequacy of the proposed CAPAs, the USFDA may:
- Accept the response and consider the matter resolved.
- Request further information or clarification.
- Conduct a follow-up inspection to verify the implementation of corrective actions.
Q: What is a USFDA Form 483?
A: A USFDA Form 483 is a document issued by an FDA inspector to a company’s management at the completion of an inspection. It lists observations of objectionable conditions or practices that may indicate a violation of the Food, Drug, and Cosmetic Act and related regulations.
Q: What is the difference between a “procedural observation” and a “data integrity” observation?
A: A procedural observation relates to deviations from established operating procedures or a need to refine existing procedures to better meet regulatory requirements. A data integrity observation suggests concerns about the accuracy, reliability, or completeness of data used to make quality decisions, which is generally considered more severe as it can impact the fundamental trustworthiness of product quality information.
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.
USFDA inspection: At Natco Pharma with 7 observations: Hyderabad
USFDA inspection: At Sun Pharma with 8 observations: Halol
USFDA inspection: At Alembic Pharma with 4 observations: Panelav
Types of inspections done by USFDA: Read in detail
USFDA issues Form 483 to Pharma Companies: Let’s know all about it
USFDA inspection: At Natco Pharma with 7 observations: Hyderabad
FSSAI: Food Labelling and Display – Chapter-19
Role of pharmacist in Healthcare system
Counterfeit Cholesterol Drugs Seized in Hyderabad: DCA Telangana
Drug alert: 186 drug samples declared as NSQ in May 2025
Key Notes on Revised Schedule M: API Part-6
USFDA inspection: At Sun Pharma with 8 observations: Halol
Action on Fake Doctor for selling Expired Drugs: Kerala
