Inspections, Compliance, Enforcement, and Criminal Investigations
George S. Rogers DBA Marty's Italian Bakery 28-Jun-04
Department of Health and Human Services
Public Health Service
Baltimore District Office
June 28, 2004
RETURN RECEIPT REQUESTED
Mr. George S. Rogers, Owner
George S. Rogers DBA Marty's Italian Bakery
P.O. Box 154
Mt. Claire, West Virginia 26408
Dear Mr. Rogers:
The Food and Drug Administration (FDA) inspected your bakery, located at 1221 Philippi Pike, Clarksburg, West Virginia 26301, on February 26th, March 1st, and March 3rd, 2004. The inspection revealed serious deviations from the Good Manufacturing Practice (GMP) Regulations, Title 21, Code of Federal Regulations (CFR), Part 110, and from the food labeling regulations in 21 CFR Part 101.
At the conclusion of the inspection you were issued a Form FDA 483, Inspectional Observations, which
describes the insanitary conditions observed in your firm during the inspection. These conditions cause the products stored in your facility to be 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)). Specific examples include:
•Failure to take effective measures to exclude pests from processing areas. Our employee observed that the door next to the creek was open for appi•oximatcly 30 minutes with a dead rat three feet from the open door. There was also a gap of approximately one inch between the garage door of the loading dock and the building, approximately 15 feet from seven racks of moldy out-of-date product. Additionally, there were gaps in the back wall of the building approximately six to eight inches wide under the foundation providing a harborage for pests; [21 CFR 110.35(c)]
•Failure to take effective measures to protect against the inclusion of metal or other extraneous material in food. Specifically our investigator observed metal shavings in channels on wheeled baking racks used to hold baking sheets of pepperoni rolls. The metal shavings could fall on product below as baking sheets arc placed into or removed from the racks. Additionally, our investigator observed a four foot fluorescent light bulb fall from a fixture between the pepperoni roll production table and the oven used to bake bread while the firm's employees continued to rnanufacture pepperoni rolls; [21 C1hR 110.80(b)(8)]
•Failure to confine the drinking of beverages and the use of tobacco to areas other than where
food is exposed or where equipment or utensils are washed. Specifically our investigator observed more than twenty cigarette butts on the floor near and under a table being used by employees to assemble pepperoni rolls, five cigarette butts on the floor under the three compartment stainless steel sink, five cigarette butts on the floor next to a processing table, numerous other cigarette butts on the floor throughout the manufacturing area and opened containers of soda on the manufacturing table being used by employees to assemble pepperoni rolls; [21 CFR 110.10(b)(8)]
•Failure to maintain equipment to facilitate cleanirig of the equipment, specifically, there were
deep, discolored grooves on the food contact surfaces of the bread rounder rollers and holes and
gouges in the surface of the table used to assemble pepperoni rolls; [21 CFR 110.40(a)]
•Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food-contact surfaces. Specifically, our investigator observed soil on the bread rounder, manufacturing table, oven trays, and racks being used to produce bread and pepperoni rolls; [21 CFR 110.35(a))
•Failure to maintain toilet facilities in a sanitary condition. Specifically, our investigator noted
that there was no toilet paper, soap, or hand drying towels in the restroom when he arrived at 10
am and when he departed shortly after 3 pm. There was also trash and used tissues strewn on the floor of the restroom; [21 CFR 11037(d)(1)]
•Failure to store rubbish in a manner that minimizes the potential for waste becoming an attractant and harborage or breeding place for pests. Specifically, racks of moldy product, and piles of rubbish were found inside the building in manufacturing areas. [21 CFR 110.37(f)]
During the inspection our investigator collected labels for your products "MARTY'S SQUARE PIZZA SHELLS," "MARTY'S ROUND LOAF," and "MARTY'S PEPPERONI ROLLS." Our review of these labels, together with other evidence from the inspection, reveals that the products are misbranded under Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343), as follows:
MARTY'S SQUARE- PIZZA SHELLS
•Your "MARTY'S SQUARE PiZZA SHELLS" are misbranded under Section 403(q) of the Act in that the label fails to bear nutrition labeling as required by 21 CFR 101.9.
•The product is further misbranded under Section 403(r)(1)(A) of the Act because the "reduced calorie" claim does not identify the reference food and state the percent or fraction difference in calories between the two foods in immediate proximity to the claim, as required by 21 CFR 101.60(b)(4)(ii)(A) (e.g., "1/3 less calories than regular pizza shells").
•The product is further mishranded under Section 403(i)(2) of the Act because the ingredient
statement does not list the ingredients by their common or usual name in descending order of predominance by weight, as required by 21 CFR 101 .4(a). According to your label, the product contains "minimum salt, water, flour, yeast & yeast food," although this is not the order of predominance of these ingredients according to the recipe provided to the FDA investigator during the inspection.
•The product is further misbranded under Sections 403(a)(1) and 403(e)(1) of the Act because the label does not identify the current place of business of the manufacturer, packer, or distributor, as required by 21 CFR 10l .5(a). Your product label erroneously lists your former location, "1-79, EXIT 115, QUIET DELL, WV 26408."
MARTY'S ROUND LOAF
•Your "MARTY'S ROUND LOAF" is misbranded under Section 403(r)(1)(A) of the Act because the "reduced caloric" claim does not identify the reference food and state the percent or fraction difference in calories between the two foods in immediate proximity to the claim, as required by 21 CFR 101 .60(b)(4)(ii)(A).
•The product is also misbranded under Sections 403(a)(1) and 403(e)(1) of the Act because the label does not identify the current place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). Your product label lists an incorrect address.
MARTY'S Pepperoni Rolls
•Your product identified as "MARTY'S Pepperoni Rolls" is misbranded under Section 403(q) of the Act in that the label fails to bear nutrition labeling as required by 21 CFR 101.9.
•The product is further misbranded under Section 403(i)(2) of the Act because the product is
formulated from two or more ingredients, but the label fails to bear a list of ingredients by common or usual name in descending order of predominance by weight, as required by 21 CFR 101.4(a).
•The product is further misbranded under Sections 403(a)( I) and 403(e)(1) of the Act because the label does not identify the current address of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). Your product label erroneously lists your former location, "1-79, EXIT 115, QUIET DELL, WV 26408."
You should take prompt action to correct these deviations. These deviations may result in regulatory
action, being initiated by the FDA without further notice, including seizure and/or injunction. This letter may not list all the deviations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and FDA regulations You are responsible for implementing procedures to prevent further violations of the Act and all applicable regulations.
Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations and to prevent recurrence. Your response should outline the specific things that you are doing to correct these deviations. You may wish to include in your response documentation and written verification procedures or 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 deviations.
We note that the principal display panel (the part of the label that is most likely to be displayed o examined under customary conditions of display for retail sale) of your "MARTY'S SQUARE PIZZA SHELLS" and "MARTY'S ROUND LOAF" products does not include a net quantity of contents statement. We advise that the principal display panel of a food label must include a net quantity of contents statement. If the product label bea rs one or more alte rn ate principal display panels, the net quantity of contents statement must be duplicated on each principal display pane) [21 CFR 101.105(e)]
For your "MARTY'S SQUARE PIZZA SHELLS" product, we note that the term "ENRICHED" is pri nted above the list of ingredients. In the absence of any information that identifies the type of flour used to manufacture this product, we are unable to determine whether the term "enriched" refers to the type of flour used in the product, to another ingredient, or to the product as a whole. If it refers to the type of flour used in the product, we advise that enriched flour is a multi-ingredient food subject to a standard of identity in 21 CFR 137.165. Therefore, when enriched flour is used as an ingredient in a finished food, it must be designated in the food's statement of ingredients in one of the following two ways: as "enriched flour" followed by a parenthetical list of the component ingredients in descending order of predominance in the enriched flour, or by listing the components of the enriched flour in descending order of predominance in the finished food, without listing the enriched flour itself [21 CFR 101.4(b)(2)].
Additionally, we note that the first ingredient listed in the "MARTY'S ROUND LOAF" ingredient
statement is "BLEACHED ENRICHED FLOUR (MALTED BARLEY FLOUR, POTASSIUM BROMATE, NIACIN, REDUCED IRON, THIAMIN MONONITRATE, RIBOFLAVIN)." The standard of identity for enriched flour requires that the product include folic acid [21 CFR 137.165(a)]; however, the parenthetical ingredient statement for bleached enriched flour on the label of "Round Loaf" does not include folic acid.
After reviewing your labeling for your "ROGER'S AND MAZZA'S "LARGE CHEESE" PEPPERONT ROLL," "ROGER'S AND MAZZA'S "SMALL CHEESE" PEPPERONI ROLL." and "ROGER'S AND MAZZA'S "LARGE HOT CHEESE" PEPPERONI ROLL" products, we have the following comments:
•The labels for these products list multi-ingredient foods (e.g., pepperoni, cheese) as ingredients of the finished food; however, the ingredient statement does not identify the components of these ingredients, as required by 21 CFR 101.4(b)(2).
•The "SHORTENING" ingredient is not declared by its specific common or usual name, as required by 21 CFR 101.4(b)(14).
Your reply should be sent to the Food and Drug Administration, 6000 Metro Drive, Suite 101,
Baltimore, Maryland 21215, Attention: Elizabeth Laudig, Compliance Officer. Ms. Laudig can be reached at (410) 779-5441.
Cc: Linda Jones, R.S. Assistant Director
Public Health Sanitation Division
815 Quarrier Street, Suite 418
Charleston, West Virginia 25301-2616