- Losurdo Foods, Inc.
- Issuing Office:
- New York District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
September 22, 2014
WARNING LETTER NYK-2014-60
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Mark JX Losurdo
CEO & President
Losurdo Foods, Inc.
20 Owens Road
Hackensack, New Jersey 07601
Dear Mr. Losurdo:
The U.S. Food and Drug Administration (FDA) inspected your facility located at 78 Sam Stratton Road, Amsterdam, New York 12010 on February 10-21, 2014 and March 18, 2014 which manufactures frozen dough, cannoli cream, breadcrumbs and garlic spread as well as grating and repacking various cheese products.
During our inspection, FDA investigators collected an environmental sample consisting of multiple swabs taken from various areas within your facility. FDA laboratory analyses of the environmental swabs found the presence of a human pathogen Listeria monocytogenes (L. monocytogenes) in your facility. Additionally, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). Based on FDA’s analytical results from the environmental sample and the inspectional findings documented during the inspection, we have determined that your food 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 that they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health.
Further, our investigator obtained product labels during the inspection for several of your products. We have reviewed these labels and found violations of the food labeling regulations, 21 CFR Part 101, that cause your products to be misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343]. You can find the Act and FDA’s regulations through links in FDA’s home page at www.fda.gov
FDA laboratory analysis of the environmental sample collected on February 19, 2014, confirmed that eighteen (18) of the seventy-two (72) environmental swabs were positive for L. monocytogenes. The positive swabs were collected from various locations within your Cheese Room and Bun Room which included direct food contact surfaces such as the sifter and cheese wheel cutting table. Analysis using Pulsed-Field Gel Electrophoresis (PFGE) showed that all but one of the L. monocytogenes isolates obtained from the FDA environmental sample collected on February 19, 2014 were indistinguishable by both a primary and secondary enzyme pattern. The presence of L. monocytogenes in your facility is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens in your facility to prevent contamination of food.
L. monocytogenes is a pathogenic bacterium that is widespread in the environment. It can proliferate in food processing facilities without proper controls, where it may contaminate food. Consuming these contaminated foods can lead to a severe, sometimes life-threatening illness called listeriosis: an atypical foodborne illness of major public health concern due to the severity of the disease, its high case-fatality rate, long incubation, and predilection for individuals with underlying conditions.
We acknowledge your submission of a report to the Reportable Food Registry (RFR) and recall of your pecorino romano grated cheese produced on February 19, 2014. In communications with your attorney, Mr. David Durkin, as to the basis for limiting your recall to the production of February 19, 2014, Mr. Durkin replied to our Recall Coordinator that the assurance was based on the existing full cleaning and sanitation protocol for equipment and the processing room that occurs at the end of each production shift, and which occurred on the day of the inspection during which the FDA swabs were taken.We also acknowledge receipt of your response dated March 7, 2014, as well as your electronic mail communications of March 18, 19, 20, 21, 24, 2014 and April 7, 2014, reporting additional cleaning and swabbing throughout your facility. Your March 19 & 20, 2014 swab samples detected additional L. monocytogenes findings and prompted your firm to cease all cheese production in an attempt to clean and sanitize your facility, and to determine the root cause of contamination.
Additionally, FDA investigators also observed the following significant violations of the Current Good Manufacturing Practice regulation for foods [21 CFR 110]:
1. Your firm failed to employ appropriate quality control operations to ensure that food is suitable for human consumption, as required by 21 CFR 110.80. Upon review of your firm’s environmental microbial testing conducted between June 5, 2013 through December 3, 2013, our investigators found eleven (11) positive results for Listeria species in your Bun and Cheese rooms, six (6) of which were identified from food contact surfaces. Your SOP entitled (b)(4), revised on May 2, 2013, identified locations throughout your processing environment where the positive Listeria species were found, these locations include but are not limited to the following food contact surfaces: the table top and wire cutter of your cheese slicing table, the inside surface of your cheese grater, and the interior surface of a stainless steel tub used to catch dough. Listeria species were also found on non-food contact surfaces, including but not limited to, the underside of the drain cover and bottom drain trench in both your cheese room and dough rooms.
2. Your firm failed to ensure work-in-process is handled in a manner that protects against contamination, as required by 21 CFR 110.80(b)(5). Specifically, our investigators observed:
- During pizza dough manufacturing, an open container with sugar inside the sink used for cleaning equipment.
- Open containers of lard for pizza dough on top of the sink.
- Boxes of gloves on top of the stainless steel cheese cutting table during pecorino romano grated cheese manufacturing.
- A carton on top of a drain in the Bun Room during manufacturing of pizza dough balls.
3. Your firm failed to ensure employees 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 contamination of food, as required by 21 CFR 110.10(b). Specifically, our investigators observed:
- An operator touched his face with gloves during packaging of pizza dough balls
- Personnel touched their cloth with gloves during packaging of pizza dough balls
- Personnel with their uniform pant legs dragging on the floor during manufacturing of pizza dough balls
- An employee’s long sleeve sweater in contact with pecorino romano grated cheese and inside the packaging plastic bag
- An employee’s bare arm in contact with the inside of a dusting flour paper bag during manufacturing of pizza dough balls
- An employee’s bare arm in contact with the inside of a rice flour paper bag during manufacturing of pecorino romano grated cheese
4. Your firm failed to ensure effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, our investigators observed:
In the Bun Room during the manufacturing of pizza dough balls:
a. Approximately 3 live beetle-like insects, 3 inches under the wheat flour silo’s rotary valve
b. Approximately 6 live beetle-like insects, 3 feet from the wheat flour silo’s rotary valve at the edge of your building foundation wall
c. One live beetle-like insect, 4 feet from the wheat flour silo’s rotary valve at the support column of the silo
d. Approximately more than 100 live beetle-like-insects and more than 500 dead beetle-like insects inside the space between vinyl wall of the wheat silo area and the building wall
In the Cheese Room:
a. Approximately 6 live insects inside and outside the (b)(4) box approximately 2 feet from the mozzarella shredder;
b. Approximately 4 live insects outside the electric outlet approximately 2 feet from the equipment cleaning sink; and
c. Approximately 5 live insects outside the electric switch for the cheese grating machine approximately 2 feet from the equipment cleaning sink.
5. Your firm failed to maintain buildings and fixtures in repair sufficient to prevent food from becoming adulterated, as required by 21 CFR 110.35(a). Specifically, our investigators observed:
- Three openings on the vinyl wall of the flour silo area: one opening near the flour silo had a live beetle-like insect crawling out of the space between the vinyl wall and the building walls.
We acknowledge receipt of your responses dated March 7, 2014 and June 3, 2014, addressing the objectionable conditions noted on the Form FDA 483 issued on February 21, 2014. Your responses included descriptions of corrective actions your firm has taken to address the FDA noted observations of concern and photographic evidence showing some of these corrections. Please provide detailed information of the steps you have taken to ensure long term correction of the observed conditions. Furthermore, we also acknowledge in your response the description of corrective actions being taken to address the findings of L. monocytogenes within your facility. These corrective actions included hiring (b)(4) to assist in locating the root cause of your contamination and validating cleaning and sanitation protocols; hiring (b)(4) to perform a deep cleaning of your production rooms and equipment; and performing environmental swabbing throughout your facility. However, your response lacked details regarding the identified source of pathogen contamination, the types of cleaning and sanitation protocols that were developed and validated for your firm, the type of deep cleaning treatment performed in your facility, and the timeframes within which your firm took environmental swabs. Please provide us any scientific information you relied upon in determining that these corrective actions are appropriate so that we can evaluate that information.
Based on our review of your product labels we have determined that your “Italian Style Flavored Bread Crumbs 5 lbs.,” and “Bel Capri Garlic Spread 2 lbs” products are misbranded within the meaning of section 403 of the Act ) [21 U.S.C. § 343], because they do not comply with FDA’s labeling regulations under 21 CFR Part 101.
1. Your “Bel Capri Garlic Spread” and “Italian Style Flavored Bread Crumbs” products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels fail to declare the major food allergens, milk, soy, wheat, as required by section 403(w)(1) of the Act.
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:
a. 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
b. 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., “flour (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)].
“Italian Style Flavored Bread Crumbs”: Are manufactured using milk or whey and wheat; however, your labels fail to declare the major allergen milk and wheat.
“Bel Capri Garlic Spread” and “Italian Style Flavored Bread Crumbs”: Are manufactured using soy; however, your labels fail to declare the major allergen soy.
2. Your “Bel Capri Garlic Spread” and “Italian Style Flavored Bread Crumbs” products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they are fabricated from two or more ingredients, but the labels fail to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients, as required by 21 CFR 101.4. Specifically,
a. Margarine is used in the manufacturing of your “Bel Capri Garlic Spread” product. The ingredient margarine is a standardized food that consists of two or more ingredients; however, your label fails to declare the sub-ingredients for margarine.
b. Romano cheese is used in the manufacturing of your “Italian Style Flavored Bread Crumbs” product. The ingredient romano cheese is a standardized food that consists of two or more ingredients; however, your label fails to declare the sub-ingredients for romano cheese. Additionally, your label fails to declare the sub-ingredients for the bread crumbs ingredient.
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.
3. Your “Bel Capri Garlic Spread” product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that its product label is false or misleading. Specifically, the label declares butter as the second ingredient; however, butter is not an ingredient used in the manufacture of this product.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are doing to correct these violations. You should include in your response, documentation such as environmental testing results for microorganisms, sanitation records, a copy of your revised labels 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.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action, including seizure and/or injunction, without further notice.
Additionally, we note that the finished product label stencil for the “Shredded Mozzarella Part Skim” does not meet all labeling requirements. The finished product label must bear all the mandatory labeling information as required in 21 CFR Part 101, as well as declaration of any major food allergens.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s 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.
Your written response should be sent to Lillian C. Aveta, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact Compliance Officer Lillian C. Aveta at (718) 662-5576 or Email at Lillian.Aveta@fda.hhs.gov
Ronald M. Pace
New York District
cc: Gerard Orcutt
Losurdo Foods, Inc.
78 Sam Stratton Road
Amsterdam, New York 12010