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

Osaka: Takeda has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for HyHub and HyHub ...

The USFDA has classified the outcome of the inspection as ‘Voluntary Action Indicated’ (VAI) and has officially closed the ...

Zydus Lifesciences got USFDA approval for Celecoxib capsules (50–400 mg) to treat arthritis, JIA, and AS. Made in Ahmedabad, ...

The company is going to announce results for the quarter ended June 30th, 2025 on July 23, 2025 after the board meeting.

Dr. Reddy's Laboratories receives a Form 483 with seven observations from the USFDA after an inspection of its Srikakulam ...

Dr Reddy’s received a Form 483 with seven USFDA observations after inspecting its Srikakulam manufacturing plant in Andhra ...

Dr Reddy's Laboratories has received a Form 483 with seven observations from the US health regulator for its Srikakulam-based ...

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

The USFDA says diced onions used at McDonald’s have not been linked to the E. coli outbreak. Investigators believed they have narrowed their focus to slivered onions only.