An OTC monograph drug facility (MDF) is a foreign or domestic business or other entity that, in addition to meeting other criteria, is engaged in manu...
A manual toothbrush is a medical device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque an...
A contract manufacturing organization (CMO) facility is an OTC monograph drug facility where neither the owner nor any affiliate of the owner or facil...
Facilities that meet the definition of a “qualified facility” under the Preventive Controls for Animal Food rule and that began manufacturing, process...
FDA: If labels do not include a domestic phone number through which the manufacturer, distributor or retailer identified may receive a report of a ser...
Spirulina extract may be safely used for coloring at levels consistent with good manufacturing practice: beverage mixes and powders, yogurts, custards...
Up to 40% of the drugs Americans take are manufactured outside US borders, while 80% of the active pharmaceutical ingredients come from foreign source...
It is widely recognized that the FDA will never have the capacity to screen all imported drug shipments. So, the new risk-based approach should help i...
Your next FDA Biennial Registration Renewal is between October 1 and December 31, 2022. When you are competing with 300,000+ companies to renew your F...
