| Public Health Service Food and Drug Administration |
New Orleans District |
Department of Health and Human Services
January 24, 2011
WARNING LETTER No. 2011-NOL-07
UNITED PARCEL SERVICE
Delivery Signature Requested
Thomas L. Tiller, Owner
Tiller Biscotti & Cookie Company
4765 South Mcraven Road
Jackson, Mississippi 39204-2036
Dear Mr. Tiller:
On September 14-15 and 29, 2010, a Food and Drug Administration (FDA) investigator inspected your biscotti manufacturing facility, located at 4765 South Mcraven Road, Jackson, Mississippi. We found you have serious deviations of Title 21 of the Code of Federal Regulations, Part 110 (21 CFR 110), Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food. Because your biscotti products have been prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health, your bakery products are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 342(a)(4)]. In addition, the labeling for your almond biscotti product is misbranded under Section 403 of the Act [21 U.S.C. § 343]. Regulations implementing the food labeling requirements of the Act are found in 21 CFR 101. You may find the Act and the regulations through links in FDA’s Internet home page at http://www.fda.gov
During the inspection, our investigator discussed with you her evaluation of your firm’s compliance with applicable aspects of the CGMP regulations. The following deviations were noted during the inspection:
1. You failed to take necessary precautions against contamination of food, food contact surfaces, and food packaging systems with foreign substances, as required by 21 CFR 110.10(b)(9). Specifically, our investigator observed the following:
• On September 14, 2010, you manufactured on the same equipment, almond biscotti, containing tree nuts/almonds, before processing chocolate cube biscotti, which does not contain tree nuts/almonds. You failed to clean the equipment between manufacturing the batches of almond and chocolate cube biscotti.
• You handled non-sanitized objects, such as a door, and then continued preparing raw product for baking without washing or sanitizing your hands.
2. You failed to confine eating food and drinking beverages to areas other than where food may be exposed or where equipment or utensils are washed, as required by 21 CFR 110.10(b)(8). Specifically, our investigator observed you drinking and eating during the manufacture of almond biscotti.
3. Food production employees did not wear beard covers or other effective hair restraints, as required by 21 CFR 110.10(b)(6). Specifically, our investigator observed you without a beard cover while mixing, dividing, and rolling dough during the manufacture of almond and chocolate cube biscotti.
4. You failed to maintain food processing equipment, containers, and utensils in a manner which protects against contamination, as required by 21 CFR 110.80(b)(7). Specifically, our investigator observed you placed a mixing bowl on the floor and then on top of the wooden block table before the table was used to prepare components during the manufacture of chocolate cube biscotti. The table was not washed or sanitized before it was used to manufacture the chocolate cube biscotti.
5. You failed to clean non-food-contact equipment surfaces as necessary to protect against contamination of food, as required by 21 CFR 110.35(d)(3). Specifically, our investigator observed the return register air vent located over the entrance doorway to the processing area with a build up of dust or residue. The vent is located directly over the wooden table used to stage raw product ingredients prior to mixing.
6. You failed to take effective measures to protect against the inclusion of extraneous material in food, as required by 21 CFR 110.80(b)(8). Specifically, our investigator observed dust on the outer lids of the plastic containers used to store finished product.
7. You failed to maintain equipment so as to facilitate cleaning, as required by 21 CFR 110.40(a). Specifically, our investigator observed a pit, approximately 1” X 1/4” deep, in the wood table used to prepare biscotti.
8. You failed to take effective measures to exclude pests from the processing area to protect against the contamination of food on the premises by pest, as required by 21 CFR 110.20(b)(7). Specifically, our investigator observed a fly in the processing area on September 8 and 9, 2010.
9. You failed to provide safety-type light bulbs and lighting fixtures which are suspended over exposed food, as required by 21 CFR 110.20(b)(5). Specifically, our investigator observed all lights in your firm’s processing area were without safety bulbs or plastic shields.
Labeling Violations
In addition, we have reviewed the label for your Almond Biscotti product and determined it is misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343] because you distribute bulk product in unlabeled plastic bags to consignees. Your product is misbranded as follows:
10. Your Almond Biscotti product is misbranded within the meaning of Section 403(w) of the Act [21 U.S.C. § 343(w)] because you fail to declare all major food allergens present in your product.
Section 201 (qq) of the Act [21 U.S.C. § 321 (qq)] defines as “major food allergens” milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredients containing proteins derived from one of these foods, with the exception of highly refined oils or ingredients derived from such oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:
• The word “Contains”, followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients [Section 403(w)(1)(A) of the Act; 21 U.S.C. § 343 (w)(1)(A)], or
• The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source that appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [Section 403(w)(1)(B) of the Act; 21 U.S.C. § 343 (w)(1)(B)].
Your Almond Biscotti product is made using wheat flour, butter, eggs, and almonds. However, your label does not declare the presence of the major food allergens wheat, milk, eggs, and almonds.
12. Your Almond Biscotti product is misbranded under Section 403(i)(1) of the Act [21 U.S.C. § 343)(i)(1)] because the product fails to bear an adequate common or usual name of the food as specified by 21 CFR 101.3(b)(2). Specifically, your label states “Almond” which is not the common or usual name of the food.
13. Your Almond Biscotti product is misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the product is fabricated from two or more ingredients, but fails to bear the common or usual name of each ingredient as specified by 21 CFR 101.4. Specifically, your product is made with several ingredients; however, your label fails to bear a declaration of ingredients.
14. Your Almond Biscotti product is misbranded within the meaning of Section 403(e)(1) [21 U.S.C. § 343(e)(1)] because the label does not contain the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
15. Your Almond Biscotti product is misbranded within the meaning of Section 403(e)(2) [21 U.S.C. § 343(e)(2)] because the label does not contain a statement of the quantity of the contents in terms of weight, measure, or numerical count as required by 21 CFR 101.105.
We note our investigator observed you manufacture four other biscotti products, Almond Blondine, Almond Chocolate, Chocolate Cube, and Lemon which are labeled in a manner similar to your Almond Biscotti product. These products must also bear labels which meet the requirements of 21 CFR 101.
The above violations are not meant to be an all-inclusive list of deficiencies in your plant. 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 or injunction.
While your 6 oz. Almond Biscotti label did not appear to be in use at the time of the inspection, and you acknowledge the majority of your products are sold in bulk form, we offer the following comments regarding this label should you decide to use it at another time:
• According to 21 CFR 101.4(b)(2), the requirement to list component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the multi-component ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food. Your 6 oz. Almond Biscotti label fails to declare multi-ingredient foods (e.g. enriched flour, butter) in accordance with these requirements.
• The nutrition information, if included on the label, must be in the format specified in 21 CFR 101.9 (e.g. set off in a box by the use of hairlines).
• Your label does not declare the name and place of business of the manufacturer, packer or distributor in accordance with 21 CFR 101.5.
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 revised labeling or other useful information, to assist us in evaluating your corrections. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed.
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 you may contact Mr. Rivero at (504) 219-8818, extension 103.
Sincerely,
/S/
Patricia K. Schafer
Acting District Director
New Orleans District
Enclosure: Form FDA 483, dated September 29, 2010
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