Get Form Fda 3177. Recall Audit Check Report

Filling out the FORM FDA 3177, Recall Audit Check Report, is an essential process for managing product recalls effectively. This guide provides step-by-step instructions to assist users in completing the form accurately and efficiently.

Follow the steps to fill out the FORM FDA 3177 online

1. To initiate the process, click the ‘Get Form’ button to access the form and open it in your online editor.
2. In Section 1, enter the recall information including the RECALL NUMBER and the RECALLING FIRM. Make sure this information matches the details provided by the recalling firm.
3. Proceed to Section 2 and fill in the PROGRAM DATA. This includes the MONITORING DIVISION and any relevant RECALLED CODE(S) or PRODUCT(S) information.
4. In Section 3, provide details regarding AUDIT ACCOUNTS. Include information for DIRECT and any SUB-ACCOUNT if applicable, along with contact PHONE NUMBERS and the FEI NUMBER of the recalling firm.
5. Section 4 focuses on CONSIGNEE DATA. Fill in the contact information for the person reached, including the NAME, TITLE, and PHONE NUMBER. Specify the TYPE OF CONSIGNEE (e.g., Distributor, Consumer) and whether they handled the recalled product.
6. In Section 5, INPUT NOTIFICATION DATA to indicate if a formal recall notice was received. Note the TYPE OF NOTICE RECEIVED and assess the CURRENT STATUS OF RECALLED ITEMS.
7. Move on to Section 6 to document the ACTION AND STATUS DATA. Indicate if the consignee followed the recall instructions and provide relevant details, including the AMOUNT OF RECALLED PRODUCT ON HAND at the time of notification.
8. Address whether a sub-recall is needed in Section 7 and confirm the AMOUNT OF RECALLED PRODUCT NOW ON HAND.
9. In Section 9, if applicable, describe any INJURIES/COMPLAINTS related to the recall. Ensure to collect relevant information if injuries or complaints are reported.
10. Finalize the form with the FDA ENDORSEMENT CHECK section, where signatures and dates are required. Ensure all relevant details are accurate before submission.
11. After completing the form, you can save changes, download a copy, print, or share the document as needed.

Complete your FORM FDA 3177 online now and ensure effective management of product recalls.