The U.S. FDA had inspected the API facility, in Mekaguda here, from June 9-13 and issued Form 483 with one observation. The regulator had classified it as “voluntary action indicated” (VAI), the ...

Natco Pharma shares slipped 2.5% to Rs 1,009 apiece on the BSE in Thursday’s trade after the company announced its plan to ...

The US Food and Drug Administration appears poised to continue with a plan to ban prescription fluoride supplements at a time ...

We need a dedicated framework that clarifies the rules, requirements and incentives for those building personalized ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

A Form 483 is issued by the US health regulator when inspectors identify conditions that may violate the Food, Drug, and ...

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

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 receives a Form 483 with seven observations from the USFDA after an inspection of its Srikakulam ...

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