Inspectors found 111 open tickets for software defects categorized as catastrophic or severe patient harm. Several safety ...

Warning letters often are not issued until a company ... At the conclusion of the inspection, the FDA issued a Form 483, Inspectional Observations, to the facility, highlighting the need for ...

Warning letters often are not issued until a company ... Ineffective corrective actions Mid America’s responses to FDA Form 483 Inspectional Observations, issued at the conclusion of both ...

Among the issues detailed in a Form 483 notice issued by the agency ... the notice was not deemed adequate, so the FDA moved ahead with a warning letter. In a regulatory filing, Applied said ...

Anderson, MS, MBA, is a former FDA Review Chemist with over 43 years ... compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues.

In separate DLL3 antibody-drug conjugate (ADC) deals, Roche licensed from Innovent Biologics and Ideaya reached for Hengrui.

The Food and Drug Administration (FDA) announced in a statement Tuesday that it has sent warning letters to companies selling unapproved weight loss drugs. The letter went to Xcel Peptides ...

Zoetis' statement notes that the FDA's action is not a "warning," but is a "'Dear Vet' letter which serves as a safety update." Veterinarian technician Justin Jones prepares a syringe with a ...

The US Food and Drug Administration has placed its most serious warning – a so-called black-box warning – on a drug used to relieve menopausal hot flashes. The FDA says women who are taking ...

Zoetis' statement notes that the FDA's action is not a "warning," but is a "'Dear Vet' letter which serves as a safety update." Librela works by blocking the pain pathway from the joint to the ...