Get the free FORM FDA 3356. Establishment Registration and Listing for Human Cells, Tissues, and ...

See Instructions for PRA Statement. FORM APPROVED: OMB No. 0910-0543. Expiration Date: 3/31/2017 1. REGISTRATION NUMBER FDA Establishment Identifier DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND

How to fill out form fda 3356 establishment

How to fill out form FDA 3356 Establishment:

1. Start by gathering all the necessary information and documents required to fill out form FDA 3356 Establishment. This may include your establishment information, such as name, address, and contact details.
2. Carefully read the instructions provided on the form to understand the specific requirements and guidelines for filling it out. Make sure to follow these instructions closely to avoid any errors or omissions.
3. Begin by entering your establishment's name, address, and other relevant details in the designated fields. Double-check the accuracy of this information to ensure that it is correct.
4. Provide information about the activities conducted by your establishment, such as manufacturing, packaging, or labeling. Fill out the appropriate sections that outline the specific operations undertaken by your establishment.
5. If applicable, provide details about any products or drugs manufactured or distributed by your establishment. This may include information like product names, FDA-approved applications, or any relevant identification numbers.
6. Be diligent in completing any additional sections or questions on the form, such as those related to quality control, compliance, or previous FDA inspections. Provide all requested information truthfully and accurately.
7. Review the completed form thoroughly before submission. Check for any errors, missing information, or inconsistencies that may need to be corrected. It is crucial to ensure that all necessary sections are properly filled out and no relevant details are overlooked.
8. Once you are satisfied with the accuracy and completeness of the form, sign and date it appropriately. This signature represents your confirmation and agreement to the provided information.

Who needs form FDA 3356 Establishment?

1. Any establishment engaged in activities related to manufacturing, packaging, or labeling of drugs or other FDA-regulated products may require form FDA 3356 Establishment. This includes pharmaceutical manufacturers, repackagers, and relabelers.
2. Entities involved in the distribution or wholesale of FDA-regulated products may also need to fill out this form. This can include wholesalers, distributors, and pharmacy chains.
3. Additionally, establishments engaged in the outsourcing of activities like manufacturing, packaging, or labeling may be required to submit form FDA 3356 Establishment.

Overall, any establishment involved in activities regulated by the FDA should be familiar with form FDA 3356 Establishment and fulfill the necessary requirements to ensure compliance with FDA regulations.

For pdfFiller’s FAQs

What is form fda 3356 establishment?

Form FDA 3356 establishment is a form used by medical device manufacturers to register their establishments with the Food and Drug Administration (FDA).

Who is required to file form fda 3356 establishment?

All medical device manufacturers are required to file form FDA 3356 establishment.

How to fill out form fda 3356 establishment?

Form FDA 3356 establishment can be filled out online on the FDA's website or submitted via mail. The form requires information such as the establishment's name, address, contact information, and type of devices manufactured.

What is the purpose of form fda 3356 establishment?

The purpose of form FDA 3356 establishment is to allow the FDA to maintain accurate and up-to-date information on medical device manufacturers and their establishments.

What information must be reported on form fda 3356 establishment?

The information that must be reported on form FDA 3356 establishment includes the establishment's name, address, contact information, and type of devices manufactured.

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