Protano & Sons Inc. 5/28/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
w/ DELIVERY CONFIRMATION
May 28, 2013
Gaetano R. Protano Jr.
Protano & Sons, Inc.
2301 N 22nd Avenue
Hollywood, FL 33020-2003
Dear Mr. Protano Jr.,
The Food and Drug Administration (FDA) conducted an inspection of your food manufacturing firm, located at 2301 N 22nd Ave. Hollywood Florida, from November 26 to December 3, 2012. During the inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110). These violations cause the food products produced in your facility to be adulterated within the meaning of Section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.
In addition, copies of your labeling were collected during our inspection. A review of your labels revealed your firm’s products misbranded in that they are in violation of sections 403(w) and 403(q) of the Act [21 U.S.C.§§ 343(q) and 343(w)]. You can find the Act and the CFR through links on FDA’s home page at http://www.fda.gov
Your significant violations are as follows:
1. You failed to take effective measures to exclude pests from your facility and to product against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, on November 26, 2012, our investigators observed the following:
- Fifteen adults and sixteen flat grain beetle larvae (Cryptolestes sp.), one adult saw tooth grain beetle (Oryzaephilus surinamensis), and one adult and three red flour beetle larvae (Tribolium sp.) both alive and dead were located on the white recycled flour from (b)(4).
- One dead larval and one dead headless pupae red flour beetle (Tribolium sp.), one dead adult and one dead larval flat grain beetle (Cryptolestes sp.) were located on mixing bowl #1 in the bread processing area.
- Sixteen live adult (Tribolium castaneum), six live and dead (Tibolium sp.) larvae, at least one hundred dead adult (Tribolium castaneum), at least ninety three dead adult (Cryptolestes sp.), and one dead pupal (Tribolium sp.) were located on bleached wheat flour in (b)(4).
- One moth flying next to a rack of uncovered baked bread products in the firm's shipping and receiving room.
- Approximately 18 dead beetle-like insects on the floor behind (b)(4) on the north side of the bread processing area.
- Insect-like trails on the floor behind and underneath (b)(4) on the north side of the bread processing area.
- Three beetle-like insects on the ledge of (b)(4) in the bread processing area.
- Seven live beetle-like insects, too numerous to count dead beetle-like insects and mold-like substances on old flour pulled from the overhead proofer on the (b)(4) equipment line.
- 12 live beetle-like insects, and old discolored (brown color) flour in tray # 2 pulled from the overhead proofer on the (b)(4) equipment line.
- Approximately 30 live beetle-like insects, too numerous to count dead beetle-like insects and mold-like substance on old flour in tray # 3 pulled from the overhead proofer on the (b)(4) equipment line.
2. Your firm failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7).
- On 11/28/2012, two windows in the employee break/holding area were observed to have no screens in place.
- On 11/29/2012, the screen on the bay door on the north side of the shipping and receiving area was observed with a tear and a 2 to 3 inch gap in between the floor and the door.
We note that you voluntarily corrected the screen tear observed in the bay screen door. In your written response you state that you have installed weather stripping to close the gap observed between the floor and the door and that you have also installed screens in the employee break room. Your response appears adequate however; you failed to provide documentation of your corrective actions. For example, providing photographs helps to demonstrate whether the corrective actions occurred and were adequate.
3. You failed to ensure that your plant and facilities were constructed in such a manner that drip and condensate from fixtures, ducts, and pipes does not contaminate food, food contact surfaces, or food-packaging materials, to comply with 21 CFR 110.20(b)(4).
Specifically, our investigator observed the following:
- On 11/28/2012, a baking tray containing processed dough for bread was stored in the retard retarding cooler uncovered, underneath an evaporator dripping condensation on the dough.
- On 11/29/2012, condensation dripping off the ceiling onto processed dough manufactured for bread in proofer room # (b)(4).
4. Your management failed to take all reasonable measures and precautions to ensure that all persons working in direct contact with food, food contact-surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against the contamination of food, as required by 21 CFR 110.10(b). Specifically:
- Employees did not wash their hands thoroughly after each absence from the work station and at any time their hands may have become soiled or contaminated [21 CFR 110.10(b)(3)]. Specifically, on 11/26/2012, an employee was observed leaving the (b)(4) bread processing line, where the employee then handled racks and trays before returning to the (b)(4) bread processing line where they handled dough without first washing his hands.
- Employees failed to wear hair nets, caps and beard covers, where appropriate, in an effective manner [21 CFR 110.10(b)(6)]. On 11/26/2012, 11/27/2012, 11/28/2012 and 11/29/2012, employees were observed to not wear a hair net or beard cover while processing dough in the (b)(4) bread processing line.
- Employees failed to confine drinking beverages to areas other than where food may be exposed [21 CFR 110.10(b)(8)]. On 11/26/2012, an employee walking through the bread processing area was observed to be drinking from a cup.
- Employees were observed to store personal belongings in an area where food is exposed [21 CFR 110.10(b)(7)]. On 11/28/2012, two (b)(4) bottles containing a clear liquid, a small container of (b)(4) salt, and a drinking cup were observed in the retard cooler where bread products were being stored. On 11/29/2012, a bottle of drinking water was observed underneath a table that was being used to manufacture pastry products in the processing area.
We acknowledge your written response dated December 14, 2012, submitted in response to the Form FDA-483, Inspectional Observations, issued to your firm on December 03, 2012. Although you stated you have implemented corrections, we find your response inadequate in that you did not provide documentation such as pest control records, photos of your corrections, or any other supporting documentation that demonstrates you are working to bring your firm into compliance with 21 CFR Part 110.
- Your Kaiser Roll product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the label for this product fails to declare the known major food allergen, wheat.
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 ingredient that contains protein 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 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, printed immediately after or adjacent to the list of ingredient, 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 (e.g. “(wheat)”), except that 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 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)].
Specifically, your Kaiser Roll product is manufactured with enriched high gluten flour, which contains wheat. However, your finished product fails to bear a label declaring the presence of wheat, a major food allergen.
- Your Kaiser Roll, Rye Bread, and Wheat Bread products are misbranded within the meaning of section 403(q)(1) of the Act [21 U.S.C. § 343(q)(1)] because the nutrition facts information is not in an appropriate format as defined within 21 CFR 101.9. Specifically:
- The labels for your Kaiser Roll product failed to declare Trans fat on the Nutrition Facts information panel, as required by 21 CFR 101.9(c)(2)(ii).
- The Wheat Bread and Rye Bread labels declare 0% DV for Trans fat. A Daily Value or % DV for Trans fat has not been established and is not provided for within 21 CFR 101.9(d)(7).
This letter may not list all the violations at your facility. You are responsible for ensuring that your food facility operates in compliance with the Act and all applicable regulations, including the Current Good Manufacturing Practice regulation (21 CFR Part 110) and food labeling regulations (21 CFR Part 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. Failure to implement lasting corrective action of these violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
FDA’s inspection also revealed that your firm sells wholesale bread products (i.e., Hoagie rolls, Egg Hamburger buns, Egg Challah rolls and Country Italian Bread or Campagnola with Raisin and Walnut) packaged in individual, clear plastic bags. Because your bread products are distributed in packaged form, they must bear required labeling in 21 CFR Part 101. For example:
- Your packaged bread products are manufactured with flour, which contains wheat. However, your finished product fails to bear a label declaring the presence of wheat, a major food allergen, as required by section 403(w)(1).
- Your packaged bread products fail to bear its common or usual name, as required in 21 CFR 101.3.
- Your packaged bread products are fabricated from two or more ingredients, but they fail to list the required ingredients by common or usual name in descending order of predominance by weight, as required by 21 CFR 101.4.
- Your packaged bread products fail to bear a label with the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
- Your packaged bread products fail to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count in accordance with 21 CFR 101.105.
We further note that, according to the labels for your Wheat Bread and Rye Bread products, the flour ingredient used in your products appears to be “Enriched Flour.” The flour ingredient declared on the product label is simply “Wheat flour.” If the flour ingredient is enriched flour, that is a multi-ingredient product and the sub-ingredients must be declared on the finished bread label, unless an exception applies. 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, or by listing the component ingredients without listing the ingredient itself in accordance with the requirements of 21 CFR 101.4(b)(2). 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.
In addition, the declaration of vegetable shortening in the Kaiser Rolls ingredient statement does not list each individual vegetable fat ingredient in the shortening in accordance with the requirements of 21 CFR 101.4(b)(14).
We request that you notify this office in writing, within 15 working days from your receipt of this letter, of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation such as certification of actions performed by a licensed exterminator, other actions performed to control unauthorized entrance of pests, plans on how you plan to protect food products from possible contamination, and/or any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining violations.
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: Carla A. Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland Florida 32751. If you have questions regarding any issue in this letter, please contact Carla at (407) 475-4730.
Emma R. Singleton
Director, Florida District