Dr Reddy's Laboratories Ltd.'s formulations manufacturing facility was given "Form 483" with seven observations from the ...

GAITHERSBURG, Md., April 21, 2021 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration (FDA) has completed its inspection of Emergent BioSolutions’ (NYSE:EBS) Baltimore-Bayview facility and ...

Piramal’s latest FDA reprimand comes after the company disclosed the receipt of a separate Form 483 at its API facility in Riverview, Michigan, last February.. The company noted that the writeup ...

The FDA injected a Form 483 frown into Revance Therapeutics’ plans to gain regulatory approval for its Botox rival daxibotulinumtoxinA, citing quality control and records i ...

Mumbai: Pharma major Lupin has received multiple observations from the U.S. Food and Drug Administration (USFDA) following ...

Importantly, FDA also states that timely Form FDA 483 responses that include “appropriate corrective and preventive actions could impact FDA’s determination of the need for subsequent Agency ...

Natco Pharma shares slipped 2.5% to Rs 1,009 apiece on the BSE in Thursday’s trade after the company announced its plan to ...

Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel. Q. We are a US-based start-up company, and we are ...

FDA inspected the company and issued a Form FDA 483 List of Inspectional Observations, noting non-compliance with Quality System regulations and marketing new, unapproved devices.

The FDA uses the Form 482, establishment inspection report and other relevant information to determine action against NECC. The inspection report has not been completed. Release of the Form 483 ...

Enhance FDA compliance with our expanded training on inspection processes, common issues, and strategies for prevention. Gain insights into Form 483 and warning letter prevention, root cause analysis, ...