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FDA Recall Audit Check Report Instructions

This file provides detailed instructions for completing the FDA Recall Audit Check Report. It includes information on recall details, program data, audit accounts, and consignee data. Useful for those involved in managing FDA recalls.

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How do I fill this out?

To fill out this form, ensure you have all necessary recall details on hand. Follow the provided instructions for each section carefully. This guide will help you complete the form accurately.

How to fill out the FDA Recall Audit Check Report Instructions?

1
Gather all relevant recall information.
2
Fill out the program data and audit accounts sections.
3
Complete the consignee data and notification data.
4
Provide action and status data along with sub-recall information.
5
Sign and date the form, then submit it as instructed.

Who needs the FDA Recall Audit Check Report Instructions?

1
FDA compliance officers needing to document recall details.
2
Manufacturers managing product recalls.
3
Distributors tracking recalled products.
4
Retailers ensuring compliance with recall notices.
5
Healthcare providers reporting recalled medical products.

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What are the instructions for submitting this form?

What is the purpose of this form?

Tell me about this form and its components and fields line-by-line.

What happens if I fail to submit this form?

How do I know when to use this form?

What are the instructions for submitting this form?

Submit the completed Recall Audit Check Report to the appropriate FDA division. Ensure all required fields are filled and the form is signed. Contact your FDA monitoring division for the specific submission email or fax number. For online submissions, follow the guidelines provided on the FDA website. Keep a copy of the submitted form for your records.

What is the purpose of this form?

The purpose of this form is to document and manage FDA-regulated product recalls accurately. It helps manufacturers, distributors, and healthcare providers track recalled products and ensure compliance with recall notices. Completing this form ensures proper documentation of recall activities and adherence to FDA protocols.

Tell me about this form and its components and fields line-by-line.

This form contains multiple sections for comprehensive recall documentation. Each field captures specific information necessary for a complete recall audit.

1. RECALL INFORMATION: Includes Recall Number, Recalling Firm, Recalled Codes, and Products.
2. PROGRAM DATA: Program data for FDA Users Only.
3. AUDIT ACCOUNTS: Direct and Sub-Account details, including Monitoring Division and FEI Number.
4. CONSIGNEE DATA: List of contacted consignees and details about their role and product receipt.
5. NOTIFICATION DATA: Information about the recall notice and consignee actions.
6. ACTION AND STATUS DATA: Current status of recalled items and related actions.
7. SUB-RECALL: Information about subsequent distributions from consignees.
8. INJURIES/COMPLAINTS: Consignee awareness of any injuries, illnesses, or complaints.
9. REMARKS: Additional notes and actions taken if product was still available for sale or use.
10. SIGNATURES: Signature fields for final approval and endorsement.

What happens if I fail to submit this form?

Failure to submit this form can result in non-compliance with FDA regulations. This may lead to enforcement actions and possible fines.

Regulatory Non-Compliance: Failure to document and submit recall information as required by FDA guidelines.
Penalties: Potential fines and enforcement actions due to non-compliance.

How do I know when to use this form?

Use this form when a product recall is initiated and must be documented as per FDA regulations. It ensures all recall activities are accurately tracked and compliant with guidelines.

1. Initiating a Recall: Document recall details from the outset.
2. Tracking Recalled Products: Ensure all recalled products are accounted for and handled properly.
3. Notifying Consignees: Inform consignees and document their actions.
4. Ensuring Compliance: Verify adherence to recall instructions and FDA regulations.
5. Finalizing Recall: Complete and submit the form for final recall audit and review.

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