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Get 4-5 Receipt For Samples - Fda 484. Investigations Operations Manual - Fda
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How to fill out the 4-5 receipt for samples - FDA 484 online
This guide provides a comprehensive overview of how to complete the 4-5 receipt for samples, also known as FDA 484. Understanding each section of the form is crucial for accurate submissions as per the regulations set by the Food and Drug Administration.
Follow the steps to successfully complete the FDA 484 form.
- Begin by selecting the ‘Get Form’ button to access the document. This will allow you to retrieve the form and open it for editing.
- In the first section, fill in the district address and phone number. For the FDA, you should enter '850 Third Avenue, Brooklyn, NY 11232' and the phone number '718-340-7000'.
- Next, provide the name and title of the individual responsible for the samples, such as 'Richard A. Frost, General Manager' and the date of completion.
- Enter the sample number in the designated field. For example, you could use '12-4-06'.
- You will now need to input the firm name and that firm's DEA number. For illustration, you might write 'Quality Wholesale Drug Co.' for the firm name and 'AB3632918' for the DEA number.
- Complete the address section with the firm's full address, including '3146 Front Street, Brooklyn, NY 11232'.
- In the samples collected section, describe the samples in detail. Be specific and include identifying information, such as lot and serial numbers.
- Indicate the manner in which the samples were received, selecting one option from the following: 'Provided at no charge', 'Cash', 'Purchased', 'Voucher', 'Borrowed', or 'Credit Card'. Include the amount received, for instance, '$15.00' if applicable.
- Provide the names and titles of the collector(s), including printed or typed names in the designated fields, such as 'Sylvia H. Rogers' for the collector's name.
- Finally, obtain the necessary signatures from the individual responsible for providing the sample and the collector. This will officially acknowledge receipt.
- Once all fields are filled out correctly, save your changes. You may choose to download, print, or share the completed form as required.
Complete your documents online to ensure compliance with FDA standards.
To protect “confidential corporate information,” the FDA routinely redacts information in warning letters, using (b)(4) to indicate where information has been blacked out.
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