Inspections, Compliance, Enforcement, and Criminal Investigations
Mrs Wheat's Foods Fabulous Foods, Inc. 6/26/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New Orleans District|
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
June 26, 2014
WARNING LETTER NO. 2014-NOL-16
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
James B. Wheat, Owner
Mrs. Wheat’s Fabulous Foods, Inc.
2519 Agriculture Street
New Orleans, Louisiana 70122-4608
Dear Mr. Wheat:
On May 7, 8, and 16, 2014, investigators with the U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility located at 2519 Agriculture Street, New Orleans, Louisiana. The inspection found you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR), Parts 110, Good Manufacturing Practice for Human Food, and 123, Fish and Fishery Products. In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan which complies with this section or otherwise operate in accordance with the requirements of 21 CFR 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 United States Code (21 USC) 342(a)(4)]. Accordingly, your crawfish pies are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA’s Internet home page at www.fda.gov.
Your significant violations were listed on a Form FDA 483, Inspectional Observations, issued to (b)(4). Enclosed you will find a copy of this form. The deviations include the following:
1. Failure to implement the monitoring, recordkeeping, and verification procedures listed in your HACCP plan [21 CFR 123.6(b)]. “Thawing of crawfish tail meat” is listed as a Critical Control Point (CCP) in your HACCP plan, but you do not monitor the temperature of the crawfish while they are thawing in the water bath.
2. Failure for your HACCP plan to list a critical limit which will ensure control one or more hazards [21 CFR 123.6(b)]. “Cool pie filling mix” is listed as a CCP on your Crawfish Pie HACCP plan. The critical limit of the “Pie filling mixture will begin cooling within (b)(4) minutes of cooking. Mixture will not remain between (b)(4) and (b)(4) for more than (b)(4) hours and will continue cooling until product reaches 40F” does not ensure the control of the growth and toxin formation of bacillus cereus and staphylococcus aureus, for example. The product should be cooled from 135F to 70F within two hours, and further cooled from 70F to 40F within an additional four hours.
3. Failure of your HACCP plan to list one or more critical control point necessary for each of the identified food safety hazards [21 CFR 123.6(c)(2)]. Your Crawfish Pie HACCP plan does not list finished product labeling as a CCP to control for undeclared major food allergens (crustacean shellfish).
4. Failure to annually sign and date your HACCP plan [21 CFR 126.6(d)].
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information which would assist us in evaluation your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when your will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123) and the Current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Kari L. Batey, Compliance Officer, at the above address. If you have questions regarding any issues in this letter, please contact Ms. Batey at (615) 366-7808.
Thomas D. Clarida
Acting District Director
New Orleans District