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

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 Ltd.'s formulations manufacturing facility was given "Form 483" with seven observations from the United States Food & Drug Administration following an inspection, according to ...

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 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 ...

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 ...

On a typical Form 483, there is both: (a) a general citation as to the nature of the observation, usually in words that track the applicable FDA regulation; and (b) specific facts from the ...

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.

Issuance of Form 483 observations, warning letters and import alerts from the FDA poses a key risk for Indian pharma companies exporting drugs to US. Form 483 is generally the first indication of ...