Integra LifeSciences reports FDA warning letter related to quality system issues
In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the ...
FiercePharma1d
FDA warning letter reveals quality control, data integrity issues at Viatris plant in India
In a warning letter posted online late last month, the FDA scolded Viatris over a range of production slights at the ...
MassDevice1d
Integra Lifesciences receives FDA warning letter for quality systems issues at three locations
Integra Lifesciences recently received an FDA warning letter pertaining to quality systems issues at several facilities.
Food Safety News23d
FDA issues warning letters over allergen labeling failures and sanitation concerns
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 ...
Food Safety News2d
FDA warns Stew Leonard’s Holdings over misbranded cookie products following anaphylactic death
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
Law6d
Timothy A Anderson MS, MBA, Chemistry and Manufacturing Controls (CMC), cGMP Compliance, FDA Regulatory
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.
FiercePharma5d
Fierce Pharma Asia—Roche, Innovent's ADC deal; Lessons from AZ's China probes; Viatris' warning letter
In separate DLL3 antibody-drug conjugate (ADC) deals, Roche licensed from Innovent Biologics and Ideaya reached for Hengrui.
The National Law Review21d
FDA Targets GLP-1 Providers with Warning Letters
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up to receive our free e-Newsbulletins Some states have laws and ethical rules regarding solicitation and ...
The Hill20d
FDA warns companies over unapproved weight loss drug sales
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 ...
Newsweek20d
FDA Issues Vet Letter on Drug Librela Used to Control Pain in Dogs
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 ...