Free FDA-3331 - Federal

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service Food and Drug Administration Silver Spring, MD 20993

Dear Application Holder: 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 sections 505 (j) and 507 (g) 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." (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 the required 21 CFR 314.81 information within three (3) working days to the "NDA-Field Alert Report" coordinator in your jurisdictional FDA District Office, who will also be available to answer any questions that you may have regarding your reports. For your convenience, the addresses and telephone numbers of all FDA district offices are listed on the reverse side.

FORM FDA 3331 (1/09)

FDA/ORA FIELD ADDRESSES
New York District (NYK-DO) 158-15 Liberty Ave. Jamaica, NY 11433 Tel: 718-340-7000 New England District (NWE-DO) One Montvale Ave., 4th Floor Stoneham, MA 02180 Tel: 781-596-7700 Philadelphia District (PHI-DO) 900 U.S. Customhouse 2nd & Chestnut Sts. Philadelphia, PA 19106 Tel: 215-597-4390 Baltimore District (BLT-DO) 6000 Metro Dr., Suite 101 Baltimore, MD 21215 Tel: 410-779-5454 New Jersey District (NWJ-DO) Waterview Corporate Center 10 Waterview Blvd., 3rd Floor Parsippany, NJ 07054 Tel: 973-331-4902 Cincinnati District (CIN-DO) 6751 Steger Dr. Cincinnati, OH 45237-3097 Tel: 513-679-2700 Chicago District (CHI-DO) 550 W. Jackson Blvd. 15th Floor Chicago, IL 60661 Tel: 312-353-5863 Detroit District (DET-DO) 300 River Place, Suite 5900 Detroit, MI 48207-3179 Tel: 313-393-8100 Atlanta District (ATL-DO) 60 Eighth St., NE Atlanta, GA 30309 Tel: 404-347-3151 (ATL-DO) 704-344-6116 (Charlotte, R.P.) New Orleans District (NOL-DO) U.S. FDA 404 BNA Drive, Suite 500 Nashville, TN 37217-2597 Tel: 615-366-7813 Denver Federal Center 6th Avenue & Kipling Streets Bldg. 20, Entrance W10 PO Box 25087 Denver, CO 80225-0087 Tel: 303-236-3087 Florida District (FLA-DO) 555 Winderley Place Suite 500 Maitland, FL 32751 Tel: 407-475-4700 San Juan District (SJN-DO) 466 Fernandez Juncos Ave. San Juan, PR 00901-3223 Tel: 787-474-9500 Dallas District (DAL-DO) 4040 North Central Expswy. Suite 300 Dallas, TX 75204 Tel: 214-253-5200 Minneapolis District (MIN-DO) 250 Marquette Avenue, #600 Minneapolis, MN 55401 Tel: 612-334-4100 Kansas City District (KAN-DO) 11630 W. 80th Street Lenexa, KS 66214-3340 Tel: 913-752-2446 San Francisco District (SAN-DO) 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Tel: 510-337-6820 Seattle District (SEA-DO) 22201 23rd Dr., SE Bothell, WA 98021-4421 Tel: 425-483-4971 Los Angeles District (LOS-DO) 19900 MacArthur Blvd. Suite 300 Irvine, CA 92612-2445 Tel: 949-798-7600

FORM FDA 3331 (1/09)

Form Approved: OMB No. 0910-0001. Expiration Date: May 31, 2011. See OMB Statement on Reverse.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

TO: (NAME AND ADDRESS OF DISTRICT)

NDA-FIELD ALERT REPORT
TYPE OF REPORT

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. NDA/ANDA 2. NDC No.

3. GENERIC NAME OF DRUG PRODUCT

4. TRADE/BRAND NAME (if any) OF DRUG PRODUCT

5. FIRM NAME AND ADDRESS WHERE PROBLEM OCCURRED

6. FEI/CFN

7. DOSAGE FORM, STRENGTH AND PACKAGE SIZE(S)

8. LOT NUMBER(S)

9. EXPIRATION DATE(S) OF DRUG PRODUCTS

10. DATE WHEN NOTIFIED ABOUT PROBLEM(S) OR WHEN PROBLEM(S) FIRST BECAME KNOWN TO APPLICATION HOLDER

11. HOW WAS PROBLEM DISCOVERED

12. STATE PROBLEM(S)

13. ROOT CAUSE(S) OF PROBLEM(S)

14. CORRECTIVE ACTION(S) TAKEN (if any) TO PREVENT RECURRENCE OF PROBLEM(S)

15. REMARKS

NOTE: SEPARATE NARRATIVE REPORTS MAY BE ATTACHED IF DESIRED.

REPORTING ESTABLISHMENT
NAME AND MAILING ADDRESS (Include ZIP Code)

NAME AND TITLE OF AUTHORIZED REPRESENTATIVE

TELEPHONE (Include Area Code)

SIGNATURE OF AUTHORIZED REPRESENTATIVE

DATE SUBMITTED

FORM FDA 3331 (1/09)

PREVIOUS EDITION IS OBSOLETE

PSC Graphics: (301) 443-1090 EF

FARS FORM INSTUCTIONS Please fill in the location to which the form will be submitted. See Appendix for list of FDA district office addresses. Place check in the box which indicates whether the report is an initial, follow-up or final report. If the report is solely an initial report ­ please place the estimated time the final report will be submitted in the remarks section (15). If the report is an initial and final report i.e., no further submission to FDA is contemplated - check both boxes. If the report is a follow-up or final report - please place the date of the initial report in the remarks section (15). Enter the following information: (1) (2) A/NDA of the drug product involved. A/NDA numbers should match those at www.fda.gov/cder/ob/default.htm. NDC number of the product(s) involved. This includes the labeler code, product code, and if appropriate the package code. (For prescription drugs, valid NDC numbers may be found at www.fda.gov/cder/ndc.) If the product does not have an NDC number, please enter "None" and explain why in the remarks section (15). Generic name of product(s). Trade/Brand name of product(s). Name and physical address of the firm where the problem occurred. For example, if the problem occurred at a labeling site or repacking site, list that site here. For problems involving stability, place the site of the product manufacturer. If the problem involves the bulk active pharmaceutical ingredient (API), supply the name and complete address of the bulk supplier. If the site is a foreign location, include the country name. Firm Establishment Identification (FEI) number, or Central Filing Number (CFN) of the site listed in (5). If the FEI/CFN is unknown, leave blank. Dosage form of product (www.fda.gov/cder/ndc/tbldosag.txt), strength of product(s) in appropriate units (www.fda.gov/cder/ndc/tblunit.txt), and package size(s). Lot number(s) of product(s) involved. Expiration date(s) of product(s).

(3) (4) (5)

(6) (7) (8) (9)

(10) Date of discovery/notification of problem by applicant. (11) Description of how the problem was discovered, e.g., routine product testing, consumer report, etc. (12) Nature of problem identified. (13) Root cause of problem. (14) Corrective actions taken to prevent the recurrence of the problem or remove the product from the marketplace. (15) Remarks pertinent to FARS report or underlying issue. Reporting Establishment section - Enter name, address, responsible person, and submission date of the report. Please include the relationship to the product, e.g., NDA holder, manufacturer, etc. A federal 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 control number. Public reporting burden for this collection of information is estimated to average 20 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the necessary data, and completing and reviewing the collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer (HFA-710) 5600 Fishers Lane Rockville, MD 20857
FORM FDA 3331 (1/09)