Steven H. Tufo
- Tufos To Go LLC
7492 Lindbrook Ct.
Reynoldsburg, OH 43068
- Issuing Office:
- Cincinnati District Office
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Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772
May 19, 2017
Via United Parcel Service
Steven H. Tufo, Owner
Tufos To Go, LLC
7492 Lindbrook Ct.
Reynoldsburg, OH 43068
Dear Mr. Tufo,
The Food and Drug Administration (FDA) conducted an inspection of your airline catering facility, located at 2708 Palmer Rd., Hebron, Ohio, between October 26 and October 27, 2016. During our inspection, an FDA investigator documented serious violations of the Current Good Manufacturing Practice (cGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110).
These violations cause 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. You can find the Act and the FDA regulations through links in FDA's homepage at www.fda.gov.
FDA investigators observed the following significant violations of the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110]:
1. All food-contact surfaces, including utensils and food-contact surfaces of equipment, are not cleaned as frequently as necessary to protect against contamination of food, as required by 21 CFR 110.35(d). Specifically,
a. Build-up of apparent food debris was visible on the deli slicer, the large can opener blade, and the microwave.
b. Previously cleaned metal hotel pans and trays were observed with visible food soil on the food contact surfaces.
c. A cleaned utensil scoop was observed with apparent food residue on the scoop surface.
d. The spray nozzles on the rinse hoses in the three compartment food preparation sink were observed with an apparent brown residue.
e. The cutting boards used in food preparation were observed with an apparent black substance throughout the cutting surface. In addition, the boards were observed stored wet while in direct contact with other cutting boards.
2. Buildings, fixtures, and other physical facilities of the plant are not being maintained in a sanitary condition or kept in repair sufficient to prevent food from becoming adulterated within the meaning of the act. Cleaning and sanitizing of utensils and equipment is not being conducted in a manner that protects against contamination of food, food-contact surfaces, or food packaging, as required by 21 CFR 110.35(a). Specifically,
a. A build-up of debris as well as food debris was observed in areas throughout the facility including the spice storage shelving, the bottom shelving of the food preparation tables, on the floor around the three compartment sink, food preparation sink, range unit, and shelving within the walk-in refrigerator and freezer, as well as the majority of the light switches, door handles, water valve handles, ventilation hood controls, and range control knobs.
b. The welds on the inside of the three compartment sink were observed with an apparent black greasy film.
c. The floor of the walk-in freezer was observed with heavy buildup of ice from the condenser.
d. Water was observed dripping from the ceiling in the basement onto non-food related items. Pooling water was observed on the floor in the basement.
3. All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food are not being conducted in accordance with adequate sanitation principles. Appropriate quality control operations were not employed to ensure that food is suitable for human consumption. Overall sanitation of the plant is not under the supervision of one or more competent individuals assigned responsibility for this function, as required by 21 CFR 110.80. Specifically,
a. The overall supervision of the food service areas of the facility failed to demonstrate competency in sanitary operations.
b. Apparent rotting food items, including apples and a package of cheese, were observed in the storage areas.
c. Multiple opened packages of cheeses and deli meats, as well as a tray of cooked chicken breasts, were observed in the walk-in cooler without discard dates.
d. An employee was observed washing apples in the hand sink rather than a food preparation sink.
4. Sanitizing agents are not adequate and safe under conditions of use, as required by 21 CFR 110.35(d)(5). Specifically,
a. During the inspection, FDA investigators measured the sanitizing solution used to sanitize food equipment and utensils and found it contained less than 100ppm quaternary ammonia. The recommended concentration of quaternary ammonia in the sanitizer is 200-400ppm.
5. Cleaned and sanitized portable equipment with food-contact surfaces and utensils were not stored in a location and manner that protects food-contact surfaces from contamination, as required by 21 CFR 110.35(e). Specifically,
a. Investigators observed utensils used in the preparation of food being stored in a metal pan that appeared to have a build-up of food debris as well as an apparent dead insect.
b. The storage racks used to hold cleaned and sanitized metal hotel trays were observed with apparent food residue and filth.
6. Toxic cleaning compounds, sanitizing agents, and pesticide chemicals were not identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 110.35(b)(2). Specifically,
a. Investigators observed a bucket containing toilet bowl cleaner along with cleaning utensils being held in the food preparation sink.
7. Employees were not observed washing their hands thoroughly in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated, as required by 21 CFR 110.10(b)(3). Specifically,
a. Employees engaged in food preparation were observed leaving the food preparation area, retrieving additional ingredients or packaging supplies, and taking phone calls. The employees were observed changing their gloves between these events, but they were not observed washing their hands prior to changing their gloves.
8. Effective measures are not being taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically,
a. During the inspection, investigators observed multiple flying insects throughout the facility including the preparation sink, resting on packaged ingredients, and in dry storage. In addition, dead insects were observed in a container of food starch as well as on the floor in the dry storage area.
9. All plant equipment and utensils are not so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained, as required by 21 CFR 110.40(a). Specifically,
a. Shelving used in the walk-in refrigerator has been constructed from unfinished composite wood. The shelving, which is used to store closed containers of prepared food items, was observed with apparent mold growth in multiple areas.
10. Single-service articles are not being stored in appropriate containers or handled in a manner that protects against contamination of food or food-contact surfaces, as required by 21 CFR 110.35(d)(4). Specifically,
a. Investigators observed several single service trays and bowls being stored without adequate protection. In addition, several of the service trays were observed with apparent food debris on their food-contact surfaces.
11. You have failed to provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food, as required by 21 CFR 110.20(b)(1). Specifically,
a. Equipment not being used in the preparation of food was observed stored in the food preparation areas.
In addition, the Food and Drug Administration has determined that your facility is subject to the registration requirement in Section 415 of the FD&C Act (21 U.S.C. § 350d) and our implementing regulation at 21 CFR Part 1, Subpart H. The failure to register a facility as required is a prohibited act under Section 301(dd) of the FD&C Act (21 U.S.C. § 331(dd). Our records indicate that, to date, your facility has not been registered with FDA.
The owner, operator, or agent in charge of your facility, or an individual authorized by your facility's owner, operator, or agent in charge, should register the facility with FDA immediately. Registration may be accomplished on-line at http://www.access.fda.gov
. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Any facility that meets the registration requirement in Section 415 of the FD&C Act (21 U.S.C. § 350d) and our implementing regulation at 21 CFR Part 1, Subpart H and are not registered may be subject to further action, including FDA’s action to enjoin your firm from operating in violation of section 415 of the FD&C Act (21 U.S.C. § 350d) and 21 CFR Part 1, Subpart H.
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act, and the Current Good Manufacturing Practice regulation [21 CFR Part 110]. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
FDA acknowledges receipt of your written response to the Form FDA-483 received on 12/7/16. We have reviewed the information and determined that the response is inadequate because it does not include sufficient detail or supporting documentation for the corrective actions. These reported corrections will be evaluated during a subsequent inspection of your firm.
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
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, 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.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Andrew Lang, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Dr, Cincinnati, OH 45237. If you have any questions about this letter, please contact Compliance Officer Andrew Lang at 513-679-2700 x 2117.
Steven B. Barber
Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) (CGMP & PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size. See http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Dates
for PC rule compliance dates.