Medique Products is an FDA regulated facility and has been audited by the FDA numerous times with no 483s ever issued requiring any action by Prestige.
Medique conforms to the U.S. Food and Drug Administration’s Code of Federal Regulations (CFR) 21 Parts 210 and 211, current Good Manufacturing Practices (cGMP) and to the quality system standards of the Quality System Regulation for OTC drug Products CFR Part 328.
- FEI (Facility Establishment Identifier) #1833338
- DUNS #170837962
- Florida OTC License #21758
Medique also performs secondary packaging of the unit dose packets into the cartons and follows CFR Part 201 for drug facts labeling.