A Form 483 is issued at the conclusion of an inspection when USFDA investigators observe conditions that may be in violation ...

Dr Reddy's Laboratories received a Form 483 with seven observations from the USFDA for its Srikakulam-based plant in Andhra ...

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

Emcure Pharma share price rose in trade after the company announced that United States Food and Drug Administration (USFDA) ...

The U.S. FDA inspected Lupin's Pithampur Unit-2 manufacturing facility from July 08 to July 17, 2025. The inspection closed with the issuance of a Form-483 with four observations.

In June 2024, China-based Jiangsu Hengrui was also hit with a Form 483 following an inspection of its manufacturing site in the Chinese city of Lianvungang, Jiangsu province. The company, which ...

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 ...

The FDA has sent a Form 483 to Lupin listing 6 observations its inspectors made during a visit to one of the company's production plants in central India last month. However, the ticking off has ...

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 ...

Summary. I am downgrading Capricor Therapeutics, Inc. stock from Strong Buy to Hold due to FDA Form 483 risks from a Pre-License Inspection of its manufacturing facility.