Abruzzino's Italian Bakery, LLC, 12/1/09

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Baltimore District Office Central Region 6000 Metro Drive, Suite 101 Baltimore, MD 21215 Telephone: (410) 779-5454 FAX: (410) 779-570

FEI: 3004192309

WARNING LETTER

CMS # 81125

December 1, 2009

Certified Mail
Return Receipt Requested

Mr. Chris Abruzzino, Co-owner
Mr. Thomas Abruzzino, Co-owner and General Manager
Abruzzino's Italian Bakery, LLC
Route 19
Gypsy, West Virginia 26361

Dear Messrs. Abruzzino:

The Food and Drug Administration (FDA) conducted an inspection of your bakery located on Route 19, Gypsy, West Virginia, on September 16 and 21, 2009. The inspection revealed serious violations of Title 21 of the Code of Federal Regulations (CFR) Part 110 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulation. Because your bakery 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 U.S.C. § 342(a)(4)]. In addition, our review of the labeling for your bakery products and other evidence collected by our investigator indicate that your firm's Abruzzino's Pepperoni Rolls with Cheese (6 oz) product is misbranded under section 403 of the Act [21 U.S.C. § 343]. You may find the Act and FDA's regulations through links in FDA's home page at www.fda.gov.

FDA acknowledges the receipt of your letter dated September 30, 2009. However, your letter did not adequately address the CGMP violations listed below.

1. Your firm failed to take effective measures to exclude pests from the processing areas and protect against contamination of food, as required by 21 CFR 110.35(c). In addition, your firm failed to take effective measures to properly store waste in order to minimize the potential for the waste to become an attractant for pests and protect against the contamination of food, as required by 21 CFR 110.37(f). Specifically, our investigator observed the following:

• Flies in the manufacturing area that landed in an uncovered garbage can, on unbaked dough that was being prepared for manufacturing bread, rolls and pepperoni rolls, and flies flying around finished uncovered bread, rolls and pizza shells in the packaging room.

• In the manufacturing area, more than 20 rodent excreta pellets (REPs) behind equipment and a large rodent spring-trap beside a shelving unit.

• Shredded insulation behind equipment in the manufacturing area and in several areas of the storeroom.

You informed FDA that your firm conducts its own pest control. Your September 30, 2009 response letter did not include information describing additional pest control measures your firm has implemented to exclude pests from your facility. Specifically, your response stated that "[p]est control will be administered to control that issue and monitored daily." The pest control measures utilized by your firm before FDA's September 2009 inspection were not effective, as evidenced by the presence of pests within your facility. Your firm needs to take more aggressive pest control measures to eliminate pests from your facility and to keep the pests from entering your facility.

2. Your firm failed to maintain the containers used to store raw ingredients and hold raw in-process dough in a manner that protects against contamination, as required by 21 CFR 110.80(b)(7). Specifically, our investigator observed the following:

• Metal bins used to store raw ingredients for the manufacture of dough were rusted and soiled.

• A plastic tote, which comes in direct contact with raw in-process dough and is used to move raw dough to and from equipment, had jagged holes in two corners and scratches on the interior that contained black dirt.

Your September 30, 2009 response letter stated that your firm has ordered new containers to store ingredients and raw dough. We intend to verify your response concerning this violation during our next inspection.

3. Your firm failed to take reasonable precautions to ensure that over-the-counter (OTC) drug products, prescription drug products, tobacco products, personal food and beverage items, purses, and cell phones were excluded from the production areas in order to protect food, food contact surfaces or food-packaging materials from contamination with foreign substances, as required by 21 CFR 110.10(b)(9). Specifically, our investigator observed the following:

• An employee smoking a cigarette near the open exterior side door of the manufacturing area. At the time of this observation, your firm was rolling out product approximately five feet away from this door.

• Two packages of opened cigarettes were sitting on a small table in the manufacturing area and a package of cigarettes was sitting on a shelving unit in the packaging and baking area.

• Bottles of an OTC drug product and a prescription drug product were sitting on a table and a stereo speaker in the manufacturing area.

• A variety of opened soft drinks and other beverages were sitting on a stereo speaker, shelving units, a processing table, and other tables in the manufacturing area.

• In the manufacturing area, an opened partially emptied soft drink was sitting on a table used to process raw uncooked dough, and an opened beverage was sitting on a table used to package finished food products.

• A variety of food items, including but not limited to candy, cookies and crackers, were sitting on equipment and tables used to manufacture raw uncooked dough.

Your September 30, 2009 response letter stated that your firm has removed all personal items from the manufacturing area and has built a break room to house employees' personal items. We intend to verify your response concerning this violation during our next inspection.

4. Your firm failed to comply with 21 CFR 110.10(b)(1) in that some food production employees did not wear outer garments that protected against the contamination of food. Specifically, our investigator observed the following:

• Thirteen employees wore uncovered personal street clothes while mixing, dividing, and rolling dough, and assembling pepperoni rolls.

• Dough came in contact with one employee's clothing as the employee reached over the dividing table to get more dough.

5. Your firm failed to comply with 21 CFR 110.10(b)(6) in that some food production employees did not wear hair nets, beard covers, or other effective hair restraints. Specifically, our investigator observed the following:

• Thirteen employees did not wear hair nets while mixing, dividing, and rolling dough, assembling pepperoni rolls, placing bakery products into the oven, removing bakery products from the oven, and packaging bakery products.

• Five employees with facial hair did not wear beard covers while mixing, dividing, and rolling dough, assembling pepperoni rolls, placing bakery products into the oven, and removing bakery products from the oven.

In addition, based on our review of the label for your Abruzzino's Pepperoni Roll with Cheese (6 oz) product, we have found this product to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. Your firm's labeling violations include:

1. Your Abruzzino's Pepperoni Roll with Cheese (6 oz) product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343 (w)] because the product contains a major food allergen, milk, but the label fails to declare milk as an ingredient. Section 201 (qq) of the Act [21 U.S.C. 321(qq)] defines major food allergens as: milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils. Under section 403(w)(1) of the Act [21 U.S.C. § 343(w)(1)], 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;
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 that the name of the food source is not required when either (i) the common or usual name of the ingredient uses the name of the food source from which the major food allergen is derived; or (ii) the name of the food source from which the major food allergen is derived 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 in not a major food allergen).

According to the formulation information we obtained during the inspection, your Abruzzino's Pepperoni Roll with Cheese (6 oz) product is manufactured with American cheese, which contains milk and cream. However, the label of your finished product fails to declare the presence of the milk, which is a major food allergen.

2. Your Abruzzino's Pepperoni Roll with Cheese (6 oz) product also is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4(b)(2). The label of your product declares the presence of American cheese and pepperoni. According to formulation information obtained during the inspection, American cheese and pepperoni are multi-ingredient foods. The sub-ingredients for these foods are not declared in accordance with 21 CFR 101.4(b)(2).

The requirement to list these component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient. Under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.

This letter is not intended to be an all-inclusive list of the violations at your bakery. It is your responsibility to ensure that you operate your bakery in compliance with the Act, the Current Good Manufacturing Practice regulations (21 CFR 110), and the Food Labeling regulations (21 CFR 101).

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.

You should respond in writing within fifteen (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 copies of the new labels for the products that your firm manufactures, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

Please send your reply to the U.S. Food and Drug Administration, Attention: Anne Aberdeen, Compliance Officer, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have questions regarding any issues in this letter, please contact Ms. Aberdeen at (410) 779-5134.

Sincerely,

/s/

Evelyn Bonnin
District Director