FDA TEAM

Companies in the USA and 100 countries, recommend ITB HOLDINGS LLC. You could too.

Our Consultants

■ Multilingual

■ Multinational

■ Work extended hours so you do not have to

The responsibilities of our Consultants are limited and include:

  • handling services requested by our clients
  • assisting FDA in communications with domestic and foreign facilities or establishments
  • responding to questions concerning domestic or foreign facilities or establishments’ food, dietary supplements, canned food, cosmetic or drug products, as well as medical devices that are imported or offered for import into the United States
  • assisting FDA in scheduling inspections of domestic or foreign facilities and establishments
  • if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to our Consultants, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign facility or establishment.

We do understand that although supplies such as gloves, medical masks, respirators, goggles, face shields, gowns, and aprons are improving, doctors, nurses and other frontline workers caring for COVID-19 patients  still face some shortages.

Manufacturers, exporters and distributors of Personal Protective Equipment (PPE) and Hand Sanitizers are required to register their establishments with the United States Food and Drug Administration, and list their products.

Your company can rely on our Consultants’ assistance.

FDA COMPLIANCE SERVICES

Ready to get started? Check our current listing of services:

  • Company registration
  • Product listing
  • U.S. Agent Service for foreign companies
  • Also available: Label Review or Update, U.S. Toll Free Number with international call forwarding, Certificate of FDA Registration