390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
FDA Team
Our Consultants

■ Multilingual

■ Multinational

■ Work extended hours so you do not have to

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

You could too.

We take the stress out of your busy day!
Gerhard Schröder

Senior FDA Consultant

We Deliver Results

■ FOOD FACILITY REGISTRATION

■ SUPPLEMENT FACILITY REGISTRATION

■ FOOD CANNING ESTABLISHMENT REGISTRATION

■ PRIOR NOTICE

■ FOREIGN SUPPLIER VERIFICATION

■ LABEL REVIEW & DESIGN

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Shortages are leaving doctors, nurses and other frontline workers ill-equipped to care for COVID-19 patients, due to limited access to supplies such as gloves, medical masks, respirators, goggles, face shields, gowns, and aprons.

Manufacturers, exporters and distributors are invited to contact us, because FDA Registration is required.

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Some products are both cosmetics and drugs:
■ Anti-dandruff shampoos
■ Antiperspirant-deodorants
■ Moisturizers and makeup with SPF (sun protection factor)

Therefore, Drug Establishment Registration is required.

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Annual renewal of registration must occur between October 1 and December 31 of each year.

The FDA wants to speed up generic drug or OTC (Over-the-Counter) approval process by offering 8-month and 10-month reviews of abbreviated new drug applications (ANDAs).

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Labeling for approved OTC drugs and OTC drugs under the monograph system is called Drug Facts. Drug Facts includes information about the purpose and use of the drug, warnings, directions for use, and other information.

 

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Prior Notice must be provided for all food for humans and animals that is imported or offered for import into the United States.

Contact ITB HOLDINGS LLC before your next shipment to avoid FDA and CBP detention.

 

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