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ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | USA
+1 855-510-2240
FDA

 

COMPLIANCE

 

Lowest Service Fees for Domestic and Foreign Companies

 

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FOOD FACILITES & ESTABLISHMENTS

FDA Registered Food Facilities are required to provide a Unique Facility Identifier (UFI) recognized as acceptable. Currently, the only UFI recognized by the U.S. Food and Drug Administration is the Data Universal Numbering System (DUNS) Number.

Therefore, failure to update the registration with an accurate DUNS number in accordance with 21 CFR 1.230(b), will result in Cancellation of the Registration.

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Canned Food
$350.00
Dietary Supplements
$180.00
Food Facility Registration
$180.00
Food Label Review
$99.00
FSVP
$350.00
Prior Notice
$25.00
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DRUGS, COSMETICS OR MEDICAL DEVICES ESTABLISHMENTS

OTC (Over-the-Counter) drugs may be marketed without an approved application under section 505 of the FD&C Act if they meet the requirements of section 505G of the FD&C Act, including applicable conditions in an OTC Monograph.

Also, keep in mind that the U. S. Food and Drug Administration has increased the number of foreign site inspections in recent years, by posting staff in certain overseas regions.

So, be prepared.

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Drug Establishment
$350.00
Medical Devices
$350.00
MoCRA
$350.00
OTC Cosmetics
$350.00
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Affordable FDA Compliance Services for all.