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OMB Number: 05830135 Expiration Date: XX/XX/XX XXXXXAccording to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection
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How to fill out 5020 4 recall distribution

01
Gather all necessary information on the recall such as product name, lot number, expiration date, and reason for the recall.
02
Fill out the required fields on the 5020 4 recall distribution form including the supplier information, recipient information, and details of the recalled product.
03
Include any additional information or documentation required by the receiving party or regulatory authorities.
04
Submit the completed form to the appropriate parties via mail, email, or fax as instructed.

Who needs 5020 4 recall distribution?

01
Manufacturers or distributors of products that have been recalled and need to notify suppliers or recipients of the recall.
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5020 4 recall distribution refers to the process of reporting and distributing recalled products under FDA regulation 21 CFR 806.
Manufacturers, importers, and distributors of medical devices are required to file 5020 4 recall distribution.
5020 4 recall distribution forms can be filled out online through the FDA's Electronic Submission Gateway.
The purpose of 5020 4 recall distribution is to ensure that recalled medical devices are properly tracked and accounted for to protect public health.
Information required on 5020 4 recall distribution includes identification of the recalled device, reason for recall, quantity distributed, consignee information, and recall strategy.
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