Inspections, Compliance, Enforcement, and Criminal Investigations
Oxford Falls 6/16/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
June 16, 2010
WARNING LETTER No 2010-NOL-14
UNITED PARCEL SERVICE
Delivery Signature Requested
Kathy J. Mosier, Owner
Oxford Falls, Inc.
1406 Louisville Street
Starkville, Mississippi 39759-3957
Dear Mrs. Mosier:
On February 3-4, and 9, 2010, a Food and Drug Administration (FDA) investigator inspected your acidified food manufacturing facility, located at 1406 Louisville Street, Starkville, Mississippi. We found you continue to have serious deviations from FDA's Low-Acid Canned Food regulations, Title 21, Code of Federal Regulations, Parts 108 and 113, (2 I CFR 108 and 113) and Acidified Foods regulations, 21 CFR 108 and 114, and with applicable parts of the Current Good Manufacturing Practice (CGMP) provisions in 21 CFR 110. Failure to comply with all of the requirements of 21 CFR 108.25 and 108.35, and the mandatory portions of Parts 113 and 114 constitutes a prima facia basis for the immediate application of the emergency permit control provisions of Section 404 of the Food Drug and Cosmetic Act (the Act). In addition, such failure renders your acidified food adulterated within the meaning of Section 402(a)(4) of the Act [21 United States Code (USC) 342(a)(4)]. Accordingly, your acidified foods are adulterated because they have been prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act and the Acidified Foods regulations through links in FDA's Internet home page at http://www.fda.gov.
During the inspection, our investigator discussed with you his evaluation of your firm's compliance with applicable aspects of the CGMP regulations and the Acidified Foods regulations. The following deviations were noted during the inspection:
• Your firm is engaged in the processing of acidified foods but has not provided FDA with process and procedure information necessary to determine the adequacy of your acidified food processes when requested in writing in accordance with 21 CFR 108.25 (c)(3)(ii). Specifically, you have not responded to the FDA letter dated February 5, 2009, which requested information pertaining to your process filings 2009-01-21/001-011. The information requested included raw pH of the predominant low-acid food ingredients, how container closures and headspace voids are pasteurized, pasteurization method, fill temperatures and hold times as applicable, and F and z values at the reference temperature for each product.
In addition, we have reviewed the labels for several of your products and found them to be misbranded, as follows:
Your Remoulade Salad Dressing is misbranded within the meaning of Section 403(1)(2) of the Act because it is fabricated from two or more ingredients, but the label fails to bear the common or usual name of each ingredient, as required by 21 CFR I01.4(a)(1). Specifically, Ketchup, Mustard, Creole Mustard, powdered Worcestershire, and Louisiana Hot Sauce are multicomponent ingredients, which themselves contain two or more ingredients; however, the ingredient statement does not include the sub-components of each of these multi-component ingredients [21 CFR I01.4(a)(1) and 101.4(b)(2)]. This requirement may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the parenthesis; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
In addition, the label declares the ketchup ingredient as "Heinz Ketchup" and the mustard ingredient as "French's Mustard." These are not the common or usual names for those ingredients.
Oxford Falls Remoulade Salad Dressing, Blackberry Wasabi Sauce, Cranberry Wasabi Sauce, and Pomegranate Wasabi Sauce products are misbranded within the meaning of Section 403(q) of the Act [21 USC 343(q)] because the nutrition label does not declare all of the required nutrients and dietary components. Specifically, the product labels do not declare the nutrition information in accordance with 21 CFR 101.9(c) or 21 CFR 101.9(f). For example:
i The Oxford Falls Remoulade Salad Dressing nutrition label has five nutrients missing (trans fat, vitamin A, vitamin C, calcium, and iron) but does not qualify for the simplified Nutrition Facts format because it lists only two nutrients which are insignificant. In order to use the simplified format, the product must contain insignificant amounts of eight or
more of the nutrients listed in 21 CFR 101.9(f) and must place an asterisk at the bottom of the label followed by the statement "Percent Daily Values are based on a 2,000 calorie diet" when the footnote is omitted [21 CFR 101.9(f)].
ii The Oxford Falls Remoulade Salad Dressing product label fails to properly declare the serving size, as specified by 21 CFR 101.9(b) and 101.12(b).
iii The ingredient statements on your Oxford Falls Remoulade Salad Dressing, Blackberry Wasabi Sauce, Cranberry Wasabi Sauce, and Pomegranate Wasabi Sauce are not prominent [21 CFR 101.2(e)] because it is located in the middle of other label information.
We also have the following comments:
• Your Titties Salsa, Remoulade Salad Dressing, Blackberry Wasabi Sauce, Cranberry Wasabi Sauce, and Pomegranate Wasabi Sauce product labels fail to list the term "net weight" when stating the net quantity of contents [21 CFR 101.1 05(j)(3)].
• Your Remoulade Salad Dressing, Blackberry Wasabi Sauce, Cranberry Wasabi Sauce, and Pomegranate Wasabi Sauce product labels fail to include a zip code as part of the place of business address [21 CFR 101.5(d)].
• Your Medium Dix Serious Southern Salza; Hot Dix Serious Southern Salza; Mild Dix Fried Green Tomato Salsa; Blackberry Wasabi Sauce; Cranberry Wasabi Sauce; Mango Plantain
Sauce; Pomegranate Wasabi Sauce; Raspberry Chipotle Sauce; Three Pepper Peach Sauce; Bootlegger Bloody Mary Mix; Bacon Cheeseburger Blood Mary Mix; Wake Up Crabby
Bloody Mary Mix; York Harbor Blood Mary Mix; London Dry Steak Sauce; and, Mother Clucker's Buffalo Wing Sauce declare a % daily value for trans fat; however, FDA has not
established a % daily value for trans fat, and therefore it cannot be declared on the label.
The above violations are not meant to be an all-inclusive list of deficiencies in your plant. Other violations can subject the food to legal action. It is your responsibility to assure all of your products are in compliance with applicable statutes enforced by the FDA. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure, injunction and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit.
You should notify this office in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you are taking to correct these deviations. You should include in your response any documentation, such as your filed processes, pH meter calibration records, revised labeling or other useful information to assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect you to explain the reason for your delay and state when you will correct any remaining deviations.
Your reply should be directed to the Food and Drug Administration, Attention: Mark W. Rivero, Compliance Officer, at the above address. If you have questions regarding the implementation of the Acidified Foods or Low Acid Canned Food Regulations, you may contact Mr. Rivero at (504) 219-8818, extension 103, for answers and/or direction towards guidance and sources of training in achieving compliance.
We look forward to working with you to achieve a successful acidified food processing program.
H. Tyler Thornburg
New Orleans District