Dr. Reddy's receives FDA Form 483 after Hyderabad biologics inspection
Business
Dr. Reddy's Laboratories has received a Form 483 from the US Food and Drug Administration after an inspection at its biologics facility in Hyderabad, which wrapped up on June 25.
Inspectors noted seven issues, and the company says it will fix everything within the required time frame to stay on top of regulatory standards.
Dr. Reddy's commits to addressing observations
A Form 483 basically highlights areas where the facility needs to improve, but it's not a final verdict on its compliance.
Dr. Reddy's has 15 days to respond and lay out its corrective steps.
The company assures it is reviewing all observations and is committed to keeping quality high: it said it will address the observations within the stipulated timeline.