FDA warns Eatontown, NJ-based Avertix Medical about Quality System, Medical Device Reporting, and Correction and Removal violations in its production ...
FDA warns Indias Patcos Cosmetics that it is marketing adulterated over-the-counter drug products that have significant violations of CGMPs.
FDA issues a draft guidance encouraging drug developers to adopt new approach methodologies as part of a broader effort to reduce reliance on animal t...
FDA warns Parker, CO-based Oralabs about CGMP violations in its work as a contract drug manufacturer.
FDA warns Indias Flowchem Pharma about significant CGMP deviations in its production of active pharmaceutical ingredients.
BioMarin says it is discontinuing dosing and enrollment in portions of its mid-stage clinical program for Voxzogo (vosoritide) after reports of a rare...
Integra LifeSciences recalls certain neurosurgical monitoring kits, citing potential safety risks linked to a needle component used during procedures ...
FDA sends Japanese active pharmaceutical ingredient maker Alps Pharmaceutical a Form 483 from an inspection that identified multiple manufacturing and...
