Last Updated on August 13, 2025 by The Health Master
USFDA inspection
Granules India, a prominent player in the global pharmaceutical market, recently faced a USFDA inspection.
Let’s have a look into the details of the US Food and Drug Administration inspection (USFDA inspection) at one of its key facilities in Hyderabad.
USFDA Inspection ended with one observation
Granules Life Sciences Private Limited, a wholly owned subsidiary of Granules India, was the subject of a Pre-Approval Inspection (PAI) by the USFDA.
The USFDA inspection, which took place from July 28 to August 1, 2025, at the company’s manufacturing facility in Shamirpet Mandal, Hyderabad, concluded with a single observation.
As per a BSE filing by Granules India, this observation is “procedural in nature.”
The company has determined its commitment to addressing the issue and will submit a response to the USFDA within the stipulated period of time.
What is 483 Observation?
A ‘483 observation‘ is a communication from the USFDA to a company’s management, having details of the observations detected during a pharma unit inspection.
These observations are a list of deficiencies that the USFDA inspectors consider may violate the provisions of the Food, Drug, and Cosmetic Act and related acts.
Granules India
Granules India is serving over 80 countries.
With 10 manufacturing facilities, eight of which are in India and two in the USA, Granules India is a key global player of generic drugs.
Q. What is a Pre-Approval Inspection (PAI)?
A: PAI is a crucial step in the drug approval process. It is an inspection conducted by the USFDA to ensure that a manufacturing facility is capable of producing a drug consistently and reliably, meeting all quality and safety standards before the product can be approved for commercial sale in 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.
USFDA inspection: At Senores Pharma arm with 3 observations
USFDA inspection: At Unichem with 3 observations: Roha
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
Amendment: Know About the Cosmetics (Amendment) Rules, 2025
USFDA inspection: At Senores Pharma arm with 3 observations
Drug recall: Sun Pharma, Lupin, Dr. Reddy’s recall drugs
Ranitidine Under Scrutiny Over NDMA Concerns
NPPA directs Pharma industry on MRP of Non-Scheduled Formulations
All Medical Stores to install CCTV cameras: Delhi
India Inspects 905 Pharma firms: Action Against 694
Drug recall: Sun Pharma recalls 5,488 bottles of ADHD drug
