FDA Services
FDA REGISTRATION SERVICES

Coronavirus (COVID-19) Procurement Supply Chain starts with the FDA Registration of your company. Is your company manufacturing, exporting, importing or distributing Isolation Gowns, Face Masks, N95 Respirators, Ventilators, Goggles, Gloves, Hand Sanitizers or Wet Wipes?

FDA REGISTERED COMPANY

ITB HOLDINGS LLC provides the following services to domestic and foreign companies that are manufacturers, exporters, warehouses, importers, or distributors:

■ Food Facility Registration

■ Supplement Facility Registration

■ Food Canning Establishment Registration

■ Foreign Supplier Verification Program

■ Medical Device Establishment Registration

■ Drug Establishment Registration

■ Cosmetic Establishment Registration

■ U.S. Agent Service

■ Prior Notice

■ Label Review

■ Label Design

Most Food Facility Registrations are completed within 72 hours after your payment is received. Same Day Service is also available, when needed and requested.

Please keep in mind that Prior Notice filing requires FDA Registration Numbers.

Biennial Registration Renewal

All Food Facilities must renew their registration between October 1 and December 31, 2022.

Annual Registration Renewal

All Drug or Medical Device Establishments must renew their registration between October 1 and December 31, 2021.

The list of our services
Available 7 days a week
3:00 AM – 6:00 PM
Eastern Standard Time
Featured Services
FOOD FACILITY REGISTRATION
MEDICAL DEVICE REGISTRATION
DRUG ESTABLISHMENT REGISTRATION
COSMETIC REGISTRATION
COVID-19 PRODUCTS
Is your company manufacturing, exporting, importing or distributing medical devices including PPEs, or OTC drugs including hand sanitizers?

The registration of your domestic and or foreign establishment is required, and ITB HOLDINGS LLC is ready to assist.

CURRENT U.S. FDA REGISTRATION TRENDS
Food Facility
0%
PPEs
0%
Hand Sanitizers
0%
Cosmetics
0%
PPE
Personal Protective Equipment
$350
ANNUAL FEE

Face Masks

Face Shields

N95 Respirators

Gowns

OTC DRUGS
HAND SANITIZERS
$350
ANNUAL FEE

Hand Sanitizers

Registration

Product Listing

U.S. Agent Service

CONTACT ITB HOLDINGS LLC