Form 3911 Instructions - Drug Notification Page 3
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3include a short description in the blank space provided. If the specific case number(s) is known, please
indicate the number(s) in the response in item 17 or item 18.
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FAR- Field Alert Report
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BPDR - Biological Product Deviation Report
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Medwatch 3500
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Medwatch 3500A
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None
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Other
Company/Facility Information
20. Company Name & Address – Provide the following information for the company responsible for making
the notification.
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Company Name – Provide the name of the company that is responsible for making the notification.
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Address – In Address 1, provide the mailing address including number and street name; and (if
applicable) in Address 2 provide room, suite, or department.
•
City – Self explanatory.
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State/Province/Region – Self explanatory. (If U.S., use approved postal two letter abbreviation.)
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Country – Self explanatory.
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ZIP/Postal Code – Self explanatory. (If U.S., provide 5 or 9 digit ZIP code.)
21. Company Category – Select the appropriate category that describes the company responsible for making
the notification (listed in item 20).
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Manufacturer
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Wholesale distributor
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Dispenser (Pharmacy)
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Repackager
22. Unique Facility Identifier – Provide the unique identifier for the company making the notification. The
Unique Facility Identifier should be a D-U-N-S Number for the location of the company named in item 20. If the
company has not obtained a D-U-N-S number for the relevant location at the time it submits this form, this field
should be left blank. For a facility that has not been assigned a number, a number may be obtained for no cost
directly from Dun & Bradstreet ( ).
23. Contact Information – Provide the following contact information for a person at the company identified
in item 20. FDA may use this information to contact a responsible person for follow-up information about the
notification.
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Name of Contact Person– Self explanatory.
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Telephone Number – Provide the telephone number and extension of the contact person or of the
company listed in item 20.
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Email Address of Contact Person – Self explanatory
FORM FDA 3911 SUPPLEMENT (12/15) – FORM INSTRUCTIONS
Page 3 of 3
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