Form FDA 766 PDF Details

The FDA 766 form plays a critical role for businesses and individuals seeking authorization for actions under the Federal Food, Drug, and Cosmetic Act and related legislation. It is a comprehensive application used when there is a need to bring merchandise into compliance through relabeling or other specified actions. Applicants must submit this form, ideally in triplicate, or in quadruplicate if a copy is desired in return, to the Food and Drug Administration. The form outlines the applicant’s commitment to adhering to the guidelines by providing detailed information about the product, including its entry number, the carrier, and a description of how the merchandise will be brought into compliance with regulatory standards. It also includes sections for the FDA’s response to the application, specifying whether the application has been approved or denied, and under what conditions. Importantly, the form also features a section for an importer's certificate, which must be filled out once the authorized operations are complete, thus facilitating the inspection process. This detailed paperwork requires the applicant to estimate the time necessary for completing the compliance work and to agree to cover all supervisory costs in accordance with current regulations. Approved by the OMB, with a noted expiration date and a clear statement on public reporting burden, the FDA 766 form is a fundamental step for entities needing to ensure their products meet the stringent compliance standards set forth by the FDA.

QuestionAnswer
Form Name Form Fda 766
Form Length 2 pages
Fillable? No
Fillable fields 0
Avg. time to fill out 30 sec
Other names Heatlh, Redelivery, QUADRUPLICATE, FDA

Form Preview Example

SUBMIT IN TRIPLICATE (Submit in QUADRUPLICATE if you desire copy returned to you.)

APPLICATION FOR AUTHORIZATION TO RELABEL OR TO PERFORM OTHER ACTION OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AND OTHER RELATED ACTS

FORM APPROVED: OMB No. 0910-0025

EXPIRATION DATE: 12/31/08

Paperwork Reduction Act Statement An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Public reporting burden for this collection of information is estimated to average 25 hours per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the necessary data, and completing of review of the collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information to:

Department of Heatlh and Human Services

Food and Drug Administration

15800 Crabbs Branch Parkway

Rockville, MD 20855-2613

TO:DIRECTOR

District,

Food and Drug Administration

Application is hereby made for authorization to bring the merchandise below into compliance with the Act.

DATE

SAMPLE NO.

 

 

 

PRODUCT

 

 

 

 

 

ENTRY NO.

 

ENTRY DATE

 

 

 

CARRIER

AMOUNT AND MARKS

Redelivery bond has been posted by the applicant. The merchandise will be kept apart from all other merchandise and will be available for inspection at all reasonable times. The operations, if authorized, will be carried out at:

and will require

about

 

days to complete. A detailed description of the method by which the merchandise will be brought into

compliance is given in the space below:

We will pay all supervisory costs in accordance with current regulations.

FIRM NAME

APPLICANT'S SIGNATURE

ADDRESS OF FIRM

ACTION ON APPLICATION

TO: (Name and Address)

DATE

Your application has been:

Denied because:

Approved with the following conditions:

Time limit within which to complete authorized operations:

When the authorized operations are completed, fill in the importer's certificate on the reverse side and return this notice to this office.

SIGNATURE OF DISTRICT DIRECTOR

DISTRICT

DATE

FORM FDA 766 (12/04)

(See Back)

FRONT

PSC Media Arts (301) 443-1090 EF

IMPORTER'S CERTIFICATE

PLACE

DATE

I certify that the work to be performed under the authorization has been completed and the goods are now ready for inspection at:

.

The rejected portion is ready for destruction under Customs' supervision and is held at:

.

TYPED NAME OF APPLICANT

SIGNATURE

REPORT OF INVESTIGATOR / INSPECTOR

TO

PORT DIRECTOR OR DISTRICT DIRECTOR

DATE

I have examined the within-described goods and find them to be the identical goods described herein, and that

they have been:

 

on:

 

, 20

 

,

as authorized, except:

 

 

 

 

 

DATA ON CLEANED GOODS

Good Portion:

Rejections:

Loss (if any)

Did importer clean entire shipment?

Time and cost of supervision

INSPECTING OFFICER

DATE

 

 

DIRECTOR OF DISTRICT

Disposed of as noted above.

DIRECTOR OF CUSTOMS

DATE

FORM FDA 766 (12/04)

BACK

How to Edit Form FDA 766 Online for Free

By using the online PDF editor by FormsPal, you are able to fill in or change RELABEL right here. In order to make our editor better and simpler to use, we continuously work on new features, with our users' feedback in mind. Getting underway is effortless! All that you should do is stick to the next basic steps directly below:

Step 1: Firstly, access the pdf tool by pressing the "Get Form Button" in the top section of this site.

Step 2: After you open the PDF editor, you will find the form all set to be filled out. Other than filling out different blank fields, you may also perform some other actions with the PDF, particularly adding any words, modifying the original text, adding images, putting your signature on the form, and more.

So as to fill out this PDF form, make certain you provide the necessary details in every single blank field:

1. It is advisable to complete the RELABEL accurately, hence take care while filling in the parts comprising these specific fields:

Stage # 1 in completing FDA

2. Your next step would be to submit all of the following fields: TO Name and Address, DATE, ACTION ON APPLICATION, Your application has been, Denied because, Approved with the following, Time limit within which to, SIGNATURE OF DISTRICT DIRECTOR, DISTRICT, DATE, FORM FDA, See Back, FRONT, and PSC Media Arts.

FDA conclusion process explained (portion 2)

3. This stage is going to be straightforward - fill out all of the form fields in PLACE, DATE, IMPORTERS CERTIFICATE, I certify that the work to be, for inspection at, The rejected portion is ready for, TYPED NAME OF APPLICANT, SIGNATURE, DATE, REPORT OF INVESTIGATOR INSPECTOR, PORT DIRECTOR OR DISTRICT DIRECTOR, I have examined the, they have been, and as authorized except to complete this part.

Simple tips to prepare FDA part 3

4. Now fill out this next part! In this case you've got all these DATA ON CLEANED GOODS, Good Portion, Rejections, Loss if any, Did importer clean entire shipment, Time and cost of supervision, and DATE form blanks to fill in.

Step number 4 of submitting FDA

5. The very last step to complete this PDF form is critical. Be certain to fill out the appropriate fields, like Time and cost of supervision, Disposed of as noted above, DIRECTOR OF CUSTOMS, DIRECTOR OF DISTRICT, DATE, DATE, FORM FDA, and BACK, prior to finalizing. If not, it can contribute to a flawed and possibly incorrect paper!

Completing section 5 in FDA

Be really careful when filling in DIRECTOR OF CUSTOMS and Disposed of as noted above, as this is the section in which a lot of people make mistakes.

Step 3: Soon after looking through the entries, click "Done" and you are done and dusted! Get hold of your RELABEL once you register here for a 7-day free trial. Immediately gain access to the document inside your FormsPal account, together with any edits and changes being automatically kept! When using FormsPal, you're able to complete documents without the need to be concerned about information breaches or records being distributed. Our secure software ensures that your personal data is maintained safely.

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