Form 3331 NDA-Field Alert Report

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

Silver Spring MD 20993

Dear Application Holder:

Designer note: This form file is a “layout only” design
proof. It has no entry fields or functionality and has
not been optimized for 508 compliance. All those
elements will be added or updated & maintained in
the final “508 compliant” Adobe “LiveCycle” PDF file
after FDA approves this revised layout design.

The attached report form is being furnished for your convenience in complying with the “NDA-Field
Alert” reporting requirements of Section 314.81 (b)(1)(i) and (ii), as codified in Title 21 of the Code of
Federal Regulations, effective May 23, 1985:
“314.81 Other postmarketing reports.
(a) Applicability. Each applicant shall make the reports for each of its approved applications and
abbreviated applications required under this section and section 505 (k) of the act.
(b) Reporting Requirements. The applicant shall submit to the Food and Drug Administration at the
specified times two copies of the following reports:
(1) NDA-Field Alert Report. The applicant shall submit information of the following kinds about
distributed drug products and articles to the FDA district office that is responsible for the facility
involved within three working days of receipt by the applicant. The information may be provided by
telephone or other rapid communication means, with prompt written follow-up. The report and its
mailing cover should be plainly marked: “FDA-Field Alert Report.”

F
O
O

PR

(i) Information concerning any incident that causes the drug product or its labeling to be mistaken
for, or applied to, another article.
(ii) Information concerning any bacteriological contamination, or any significant chemical,
physical, or other change or deterioration in the distributed drug product, or any failure of one or
more distributed batches of the drug product to meet the specifications established for it in the
application.”
In this context, PLEASE NOTE that the information required under 21 CFR 314.81 SHOULD NOT
be submitted with reports of adverse drug reactions as described under 21 CFR 314.80, the regulation
dealing with the postmarketing reporting of adverse drug experiences.
Accordingly, please submit, via email submit button, the required 21 CFR 314.81 information within
three (3) working days to the “NDA-Field Alert Report” coordinator in the FDA district office where the
facility is located as specified on page 1, Box 1. Reports involving foreign facilities can be reported to
the jurisdictional FDA district office, where the firm’s attorney, agent or other authorized official resides
or maintains a place of business in the US. (21 CFR 314.50).
For your convenience, the addresses and telephone numbers of all FDA district offices are listed on page
ii. The e-mail submit button is located on the bottom of the last form page of the form.

FORM FDA 3331a (12/15)

Page i

FDA/ORA FIELD ADDRESSES
Select one primary address by marking the box next to an address below.
When filling out this form in Adobe Reader:
• The selected address automatically will be placed in the upper right area on form page 1, and
• its email address will be the “To” addressee in the email generated by the submit button on the last form page.

New York District
158-15 Liberty Ave.
Jamaica, NY 11433
Tel: 718-340-7000
[email protected]

Detroit District (DET-DO)
300 River Place, Suite 5900
Detroit, MI 48207-3179
Tel: 313-393-8100
[email protected]

New England District (NWE-DO)
One Montvale Ave., 4th Floor
Stoneham, MA 02180
Tel: 781-587-7500
[email protected]

Atlanta District (ATL-DO)
60 Eighth St., NE
Atlanta, GA 30309
Tel: 404-253-2263
[email protected]

Philadelphia District (PHI-DO)
Rm 900 U.S. Customhouse
200 Chestnut St.
Philadelphia, PA 19106
Tel: 215-597-4390
[email protected]

New Orleans District (NOL-DO)
U.S. FDA
404 BNA Drive, Suite 500
Nashville, TN 37217-2597
Tel: 251-344-8208, ext. 105
[email protected]

Baltimore District (BLT-DO)
6000 Metro Dr., Suite 101
Baltimore, MD 21215
Tel: 410-779-5455
[email protected]

Denver District (DEN-DO)
Denver Federal Center, Bldg 20
6th Avenue & Kipling Streets
PO Box 25087
Denver, CO 80225-0087
Tel: 303-236-3097
[email protected]

New Jersey District (NWJ-DO)
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
Tel: 973-331-4900
[email protected]
Cincinnati District (CIN-DO)
6751 Steger Dr.
Cincinnati, OH 45237-3097
Tel: 513-679-2700
[email protected]

F
O
O

PR

Florida District (FLA-DO)
555 Winderley Place Suite 200
Maitland, FL 32751
Tel: 407-475-4700
[email protected]
San Juan District (SJN-DO)
466 Fernandez Juncos Ave.
San Juan, PR 00901-3223
Tel: 787-474-9500
[email protected]

Chicago District (CHI-DO)
550 W. Jackson Blvd.
15th Floor
Chicago, IL 60661
Tel: 312-353-5863
[email protected]
FORM FDA 3331a (12/15)

Page ii

Dallas District (DAL-DO)
4040 North Central Expswy.
Suite 300
Dallas, TX 75204
Tel: 214-253-5200
[email protected]
Minneapolis District (MIN-DO)
250 Marquette Avenue, #600
Minneapolis, MN 55401
Tel: 612-334-4100
[email protected]
Kansas City District (KAN-DO)
11630 W. 80th Street
Lenexa, KS 66214-3340
Tel: 913-752-2769
[email protected]
San Francisco District (SAN-DO)
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Tel: 510-337-6790
[email protected]
Seattle District (SEA-DO)
22215 26th Ave SE
Suite 210
Bothell WA 98021
Tel: 425-302-0435
[email protected]
Los Angeles District (LOS-DO)
19701 Fairchild
Irvine, CA 92612-2506
Tel: 949-608-2900
[email protected]

Form Approved: OMB No. 0910-0001, Expiration Date: December 31, 2017. See PRA Statement on last form page.

To: (Name and Address of District, per page ii selection)

Designer note: This form file is a “layout only”
design proof. It has no entry fields or functionality
and has not been optimized for 508 compliance.
All those elements will be added or updated &
maintained in the final “508 compliant” Adobe
“LiveCycle” PDF file after FDA approves this
revised layout design.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

NDA-FIELD ALERT
Type of Report (Select all that apply)
MANDATORY

Initial

Follow-up

Final

In accordance with Section 314.81(b)(1)(i) and (ii) of the New Drug Application Regulations (21 CFR 314) promulgated under
the Federal Food, Drug and Cosmetic Act, as amended, the following information is herewith submitted:
1. Firm Name and Address Where Problem Occurred

2. DUNS/FEI Number (Fill out both numbers
if known.)

Firm Name

DUNS Number

Up to 15 characters, alpha-numeric

Address (Street address, P.O. box, company name c/o)

FEI Number
City

State/Province/Region

Country

Up to 15 characters, alpha-numeric

ZIP or Postal Code

Put DUNS # first and FEI second, to be consistent
with the order shown in #2 text label, but will switch
if you confirm you really want FEI to be first.

3. NDA/ANDA /Other Number (Select only one number type. If NDA or ANDA selected, then also fill in Number entry; skip Number if Other.)
NDA

ANDA

Other

Number:

4. NDC Number(s) (If more than one NDC number, separate with semi-colons.)

5. Generic Name of Drug Product

F
O
O

PR

6. Trade/Brand Name (if any) of Drug Product

7.a. Dosage Form

7.b. Dosage Strength and Package Size (If more than one dosage strength & package size, separate with semi-colons.)

8. Lot Number(s) and Expiration Date(s) (If more than one lot number and expiration date, separate with semi-colons.)

9. Date when notified about problem(s) or when problem(s) first became known to application holder

10. How was problem discovered?

11. State Problem(s)

FORM FDA 3331a (12/15)

Page 1 of 2

PSC Publishing Services (301) 443-6740

EF

12. Describe Root Cause(s) of Problem(s)

13. Describe Corrective Action(s) Taken (if any) to Prevent Recurrence of Problem(s)

14. Remarks

F
O
O

NOTE: Separate tables and graphs may be attached if desired.

REPORTING ESTABLISHMENT

PR

Name and Mailing Address
Reporting Establishment Name

DUNS/FEI Number (Fill out both numbers if
known.)
DUNS Number

Up to 15 characters, alpha-numeric

Address (Street address, P.O. box, company name c/o)

FEI Number
City

State (or Province or Region)

Country

Up to 15 characters, alpha-numeric
To be consistent with 2014 version, it will
be mandatory on the final fillable file to
include at least one of the above numbers.

ZIP (or Postal) Code

Name and Title of Authorized Representative

Telephone Number (Include area code)

Email Address

Date Submitted

The information below applies only to requirements of the Paperwork Reduction Act of 1995.
The burden time for this collection of information is estimated to average 8 hours per response,
including the time to review instructions, search existing data sources, gather and maintain the
data needed and complete and review the collection of information. Send comments regarding
this burden estimate or any other aspect of this information collection, including suggestions
for reducing this burden to the address to the right:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]

“An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB number.”

DO NOT SEND YOUR COMPLETED FORM
TO THIS PRA STAFF EMAIL ADDRESS.

FORM FDA 3331a (12/15)

SUBMIT

Page 2 of 2
Button does not work in this “layout only” design file.