Inspections, Compliance, Enforcement, and Criminal Investigations
Adelines Inc. 8/19/09
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
WARNING LETTER NO. 2009-NOL-16
DELIVERY SIGNATURE REQUESTED
Candy B. Popplewell, Co-Owner
1000 Dickerson Pike
Nashville, Tennessee 37207
Dear Ms. Popplewell:
On May 26 and 27, 2009, a U.S. Food and Drug Administration (FDA) investigator inspected your sandwich manufacturing facility, located at 1000 Dickerson Pike, Nashville, Tennessee. We found you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan to comply with these sections or otherwise operate in accordance with the requirements of Part 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 (USC), Section 342(a)(4)]. Accordingly, your tuna fish sandwiches are adulterated, because 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 home page at www.fda.gov.
Your significant violations were as follows:
1. You must conduct, or have conducted for you, a hazard analysis for each kind of fish and fishery product you produce to determine whether there are food safety hazards which are reasonably likely to occur, and you must have and implement a written HACCP plan to control any food safety hazards which are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). You do not have a HACCP plan for tuna fish sandwiches to control the food safety hazards of pathogen growth and toxin formation.
2. Your employee failed to wash her hands thoroughly when they may have become soiled or contaminated as required by 21 CFR 110.10(b)(3). Specifically, during the manufacturing of sausage and egg biscuits, an employee did not wash her hands after handling pre-cooked sausage patties and before adding pre-cooked eggs using an ungloved hand. In addition, the employee was observed wiping her fingers and hands on her apron throughout the manufacturing of various sandwiches.
During the inspection, copies of your labeling was collected, including labels from your Tuna; Sausage Biscuit; Bacon, Egg, & Cheese Biscuit; and, Bologna & Cheese products. Review of the labels revealed your firm's sandwiches are not labeled in compliance with the requirements of the Act and 21 CFR 101, Food Labeling.
Our review of your labels revealed the following:
1. Your Sausage Biscuit and Bologna & Cheese products are misbranded within the meaning of Section 403(w) of the Act [21 USC 343(w)]. The label fails to declare all major food allergens present in the product, as required by Section 403(w)(1) of the Act [21 USC 343(w)(1)].
Section 201(qq) of the Act [21 USC 321 (qq)] defines as major food allergens: milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient containing proteins derived from one of these foods, with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient bearing or containing, 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, as required by Section 403(w)(1)(A) of the Act [21 USC 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 appears elsewhere in the ingredient list (unless the name of the food source appearing elsewhere in the ingredient list, appears as part of the name of an ingredient that is not a major food allergen), as required by Section 403(w)(1)(B) of the Act [21 USC 343(w)(1)(B)].
• Your Sausage Biscuit product is labeled to contain "Enriched bleached flour" but fails to declare the presence of the major food allergen "wheat" on its label.
• Your Bologna & Cheese product is labeled to contain "casein" but fails to declare the presence of the major food allergen "milk" on its label.
In addition, we note your tuna product label incorrectly includes two "Contains" statements (one in the body of the ingredient statement and one immediately after the ingredient statement), each listing different allergens. If the label is to include a "Contains" statement, it should be printed immediately after or adjacent to the list of ingredients and it must include all major food allergens in the product.
2. Your Bacon, Egg, & Cheese Biscuit product is misbranded within the meaning of Section 403(i)(2) of the Act [21 USC 343(i)(2)] because its label fails to declare the common or usual name of each ingredient as specified under 21 CFR 101A(b)(2). Your label declares the ingredients for the major components separately; however, the label fails to show the "frozen egg product" ingredient includes egg whites, buttermilk, sodium phosphate and nisin preparation.
3. Your Sausage Biscuit is misbranded within the meaning of Section 403(k) of the Act [21 USC 343(k)] because it fails to declare the presence of an artificial coloring. Specifically, the sausage patty used in this product contains caramel coloring, which is not declared on the finished product label.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
Please notify this office in writing within 15 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations for which you have not already provided an adequate response, including an explanation of how you plan to prevent these violations, or similar violations, from recurring. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to Mr. Mark W. Rivero at the address above. If you have any questions about the content of this letter please contact Mr. Rivero at (504) 219-8818, extension 103.
H. Tyler Thornburg
New Orleans District
Enclosure: Form FDA 483, dated May 27,2009