Real certificates issued by Orionex Trading LLC as your authorized U.S. Agent โ the official document your facility receives after successful FDA registration.
Food Facility Registration
Real certificate issued for a client โ N & N Super Sea Food (Pvt) Ltd, Sri Lanka. Details shown with client permission for illustration purposes.
Sample food product labels reviewed for FDA compliance โ ingredient lists, allergen declarations, Nutrition Facts panel, structure/function claims.
Medical Device Establishment Registration
21 CFR Part 807 ยท FDA Device Establishment Registration & U.S. Agent Certificate โ issued on official Orionex letterhead.
Medical device labels reviewed per 21 CFR Part 801 โ intended use, warnings, UDI, contraindications, manufacturer & distributor details.
Drug Establishment Registration
21 CFR Part 207 ยท Drug Establishment Registration & NDC Labeler Code Certificate โ issued on official Orionex letterhead.
Drug labels reviewed per 21 CFR โ active & inactive ingredients, indications & usage, warnings, dosage & administration, NDC number.
Cosmetic Facility Registration (MoCRA)
Modernization of Cosmetics Regulation Act ยท Section 607 ยท MoCRA Facility Registration Certificate โ issued on official Orionex letterhead.
Cosmetic labels reviewed per FDA MoCRA regulations โ ingredient declarations (INCI), net quantity, responsible person, warning statements.