FDA 483 - Goodier Cosmetics LLC - January 15, 2026

Goodier Cosmetics LLC, a contract manufacturer in Dallas, TX, was cited for significant deficiencies in its Quality Management System during an FDA inspection. Observations included inadequate quality unit oversight, unvalidated cleaning processes for manufacturing equipment, deficient out-of-specification investigations, and incomplete raw material testing. These issues indicate a lack of adherence to established procedures and regulatory requirements for drug product manufacturing.