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

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.

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 ...

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 ...

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 ...

This time it was the release of the FDA Form 483 report containing observations of the federal food safety inspectors who were in the San Antonio produce distribution plant from Oct. 14 to 26.