Annual
Registration of Drug Establishment
Form FDA 2656e
Print or type all entries in English. This form is computer generated annually and mailed to the firm. After being reviewed by the firm, the firm signs and returns it to the FDA. Upon FDA receipt, this form registers the firm whose name appears as the reporting firm and other name(s) at the same site location for the current year. The annual registration mailing schedule is:
| January | A and B |
| February | C, D, and E |
| March | F, G, and H |
| April | I, J, K, L, and M |
| May | N, O, P, Q, and R |
| June | S and T |
| July | U, V, W, X, Y, Z, and Numbers |
INSTRUCTIONS
Review data on the form for accuracy, enter the Report Date in Item 14 and Codes for Reasons for Submission (from the list at the right) in Item 29. Make any deletions by lining through data. Enter changes or omissions in the space titled "Changes." Additional names may be entered by writing the full names in Item T61, Other Firm Names. Complete Item 328, Last Name and Initials of Person Submitting Data and Item 355, Area Code and Telephone Number. The authorizing official must sign the form. If there are more changes than can be entered on the form, identify sheet(s) of paper with the Firm Name and Establishment Registration Number (CFN) and continue additions.
This form must be returned to the FDA within 30 days after receipt.
MAILING
ADDRESS FOR FORMS AND
CORRESPONDENCE ![]()
Food and Drug Administration
Information Services Team (HFD-095)
5600 Fishers Lane
Rockville, MD 20857
If using Federal Express, DHL or
any special carrier to
return the forms, please use the following address:![]()
Food and Drug Administration
Information Management Team, HFD-095
7520 Standish Place, Room 161
Rockville, MD 20858