WARNING LETTER

Wise Spice Catering Company MARCS-CMS 533921 — October 31, 2017

Recipient:: Recipient Name

Mr. Fernando De La Cruz; Wise Spice Catering Company; Wise Spice Catering Company; 196 West 25th Street
Hialeah, FL 33010-1608
United States

Issuing Office:: San Juan District Office; United States

Office of Regulatory Affairs

Office of Human and Animal Food Operations

East Division IV

Compliance Branch

466 Avenida Fernández Juncos

San Juan, Puerto Rico 00901-3223

Tel: (787) 729-8500

November 1, 2017

WARNING LETTER

18-HAFE4-WL-01/CMS No. 533921

VIA UNITED PARCEL SERVICE

NEXT DAY - SIGNATURE REQUIRED

Mr. Fernando De La Cruz, Owner

Wise Spice Catering Company

196 West 25th Street

Hialeah, Florida 33010-1608

Dear Mr. De La Cruz:

The United States Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 196 W 25^th St, Hialeah, Florida, 33010-1608, from April 3 to April 12, 2017. During the inspection, FDA collected environmental samples (i.e., swabs) from various areas in your facility, including areas in close proximity to food and food contact surfaces. FDA laboratory analysis of the environmental swabs identified the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Based on FDA’s analytical results for the environmental swabs, we have determined that your Ready-to-Eat (RTE) products such as sandwiches and meals 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 become contaminated with filth or rendered injurious to health.

Additionally, our inspection found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 123 (21 CFR Part 123). In accordance with 21 CFR Part 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders your fish or fishery products adulterated within the meaning of section 402(a)(4) of the Act. You may find the Act, the seafood HACCP regulation, and the 4th Edition of FDA’s Fish and Fisheries Products Hazards & Controls Guidance through links on FDA’s home page at www.fda.gov.

The inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations, at the conclusion of the inspection. We acknowledge your firm’s responses dated April 24, 2017 and May 19, 2017, which include a description of corrective actions taken by your firm.

Pathogen Findings

L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening illness called listeriosis, a foodborne illness, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions.

FDA laboratory analysis of the environmental samples (b)(4) and (b)(4) collected on April 4-5, 2017, confirmed that (b)(4) environmental swabs were positive for L. monocytogenes in the sandwich room, sandwich cooler, cooler #(b)(4), warewash room, and retail area. Positive findings were identified in direct food contact or zone 1 areas, including:

the stainless steel flat surface of a display case;
the table under a slicer where condensate was observed dripping from the ceiling condenser unit onto the slicer;
a baking sheet on a food cart;
multiple horizontal guides on food carts and food cart wheels; and
a pallet holding bulk bags of raw onions.

Whole genome sequencing (WGS) analysis was conducted on the (b)(4) L. monocytogenes isolates obtained from FDA environmental samples (b)(4) and (b)(4) collected on April 4-5, 2017. WGS analysis of bacterial human pathogens provides high-resolution data, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness. WGS data can also be used to infer the evolutionary relationships (or phylogeny) within a given set of isolates as it measures each DNA position in a bacterial genome.

At this time, the WGS phylogenetic analysis found that there are (b)(4) strains of L. monocytogenes present in your facility. Of the (b)(4) strains:

(b)(4) environmental swabs ((b)(4)) are genetically identical to each other, and WGS analysis finds that these (b)(4) comprise a single (1^st) strain of L. monocytogenes.
(b)(4) environmental swab ((b)(4)) isolated a (b)(4) strain of L. monocytogenes.
(b)(4) environmental swabs ((b)(4)) comprised of a (b)(4) strain of L. monocytogenes was foundin your production environment. Comparing this (b)(4) strain isolated from the (b)(4) environmental swabs to the larger WGS database shows that it matches the L. monocytogenes isolated from a “tuna sandwich” manufactured at your facility and collected by Florida Department of Agriculture and Consumer Services (FDACS) in 2015.
Environmental swab ((b)(4)) isolated a (b)(4) strain of L. monocytogenes. Comparing this strain to the larger WGS database shows that it matches the L. monocytogenes isolated from a “ham sandwich” collected by FDACS in 2015 from your facility and a 2015 environmental swab collected by the United States Department of Agriculture (USDA) from your facility. Finding the same strain of L. monocytogenes in your production environment over multiple years indicates that this is a resident strain in your facility.
(b)(4) environmental samples ((b)(4)) collected during FDA’s 2017 inspection are genetically identical to each other and identified a (b)(4) strain of L. monocytogenes isolatedin your production environment. Comparing this strain to the larger WGS database shows that it matches the L. monocytogenes isolated from a 2014 environmental swab collected by FDACS at your facility. This L. monocytogenes strain was also found in (b)(4) 2017 FDA environmental swabs ((b)(4)). These (b)(4) swabs are genetically identical to a 2014 FDACS “turkey deluxe sandwich,” 2015 FDACS “midnight sandwich,” and 2014 FDACS “environmental isolate” sampled at your facility. Finding the same strain in your production environment over multiple years indicates a resident strain.

The (b)(4) strains identified are considered resident strains of L. monocytogenes in your facility. This is significant in that it demonstrates your sanitation efforts have been inadequate to effectively control pathogens in your facility to prevent contamination of food. Once established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product.

We acknowledge receiving your firm’s written response dated May 19, 2017, outlining the corrective actions you have taken in response to the L. monocytogenes environmental sample findings. We acknowledge that your proposed corrections include implementing an environmental testing procedure for food contact surfaces, use of a floor sanitizer, and a fruits and vegetables chlorinated and germicide solution. We will assess the adequacy of your corrective actions during our next inspection.We recommend that you review FDA’s draft guidance for industry titled, “Control of Listeria monocytogenes in Ready-To-Eat Foods” for assistance in developing your Listeria environmental sampling procedures. The draft guidance can be found at: (b)(5)

Seafood HACCP Violation:

1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that at a minimum lists the critical control points, to comply with 21 CFR Part 123.6(a) and (c)(2). A Critical Control Point (CCP) is defined in 21 CFR Part 123.3(b) as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.” However, your firm’s HACCP plan for tuna sandwiches does not list the critical control point of storage for controlling pathogen growth and toxin formation.

Your firm stores RTE tuna salad from a local supplier in your cooler until needed. FDA recommends a critical control point for storage with a critical limit that maintains the cooler at 40°F or below with continuous temperature monitoring and a visual check of the recorded data once per day.

Your response dated April 24, 2017, cannot be evaluated because it did not include a revised HACCP plan. Please submit your revised HACCP plan with your response to this letter.

This letter is not intended to be an all-inclusive list of the violations that exist in connection with your products. You are responsible for ensuring that your food manufacturing and seafood processing establishment operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

You should take prompt action to correct these violations. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and or enjoin your firm from operating.

In addition to the violations listed above, we are providing the following additional comment:

Your hazard analysis should be reassessed to determine if the time and temperature exposure during the unrefrigerated transport of the RTE tuna from the supplier to your facility needs a critical control point for controlling pathogens. If a critical control point is needed, FDA recommends a critical limit for transit time not to exceed four (4) hours and the internal temperature not to exceed 40°F when received, or the product is completely surrounded by ice, or the product has an adequate amount of cooling media, and the internal product temperature is 40°F or below when received into your facility.

Additionally, 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)). 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.

You should respond in writing within fifteen (15) working days from the date you receive 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 HACCP and verification records, 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..

If you have any questions about this letter, you may contact Mrs. Marilyn Santiago, Compliance Officer, at (787) 729-8707, or by electronic mail at: marilyn.santiago@fda.hhs.gov

Your response to this letter should be sent to the Food and Drug Administration, Office of Human and Animal Food Operations East Division IV, 466 Fernández Juncos Avenue, San Juan, PR 00901-3223, to the attention of Ms. Maridalia Torres, District Director.

Sincerely yours,

/S/

Maridalia Torres

Director San Juan District

Program Division Director OHAFO IV East