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 ...

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 ...

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 ...

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.

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.

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 ...

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 ...

* SHALL PUT TOGETHER DETAILED RESPONSE WITH ADEQUATE CORRECTIVE AND PREVENTIVE MEASURES TO ADDRESS US FDA OBSERVATIONS * ‍IN RESPONSE TO FORM 483 BY FDA AT CO'S ST LOUIS FACILITY, CO HAS ...