The Form 483 follows news that earlier this month AbbVie filed an infringement suit against Revance on five Botox patents. The suit is an attempt to freeze Revance from launching the product.

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 ...

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 ...

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 ...

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 ...

Could not be more wrong. Out of the 11 CBER-approved novel therapies in 2024 (including IVIG and vaccines), 9 (82%) were issued a Form 483 following inspection, but none resulted in a CRL.

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 ...

March 26, 2018 FDA Publishes List of All General FDA Form 483 Inspection Citations for Every Food Facility Since 2008 Elizabeth Fawell, Maile Gradison, Joseph Levitt Hogan Lovells + Follow Contact ...