| Public Health Service Food and Drug Administration |
Cincinnati District Office |
Department of Health and Human Services
VIA United Parcel Service
April 21, 2011
Steven H. Tufo, Owner and CEO
Tufo's To Go, L.L.C.
14163 Broad St. SW
Pataskala, OH 43062-9286
WARNING LETTER CIN-DO 11-161473-11
Dear Mr. Tufo:
This letter serves as your formal notification that the U.S. Food and Drug Administration (FDA) has changed the classification of your airline catering facility from "Approved" to "Provisional. " Your airline customers will be notified of this change in classification. Between December 29, 2010 and January 18, 2011, FDA conducted an inspection of your airline catering facility located at 14163 Broad St., Pataskala, Ohio. This comprehensive inspection was conducted under the authority of the Public Health Service Act (PHS Act) to determine your compliance with applicable sections of the Interstate Conveyance Sanitation regulations (21 CFR Part 1250). These regulations were promulgated pursuant to Section 361 of the PHS Act (42 USC § 264). Regulations promulgated under this section are necessary to prevent the introduction, transmission, or spread of communicable diseases. This inspection revealed significant violations of 21 CFR Part 1250 under the PHS Act. Based on these findings, your airline catering facility is classified as "Provisional."
At the conclusion of the inspection on January 18, 2011, the FDA investigator issued a list of Inspectional Observations (FDA-483) to your firm. The following are the significant violations:
1. Failure to ensure that all plumbing is designed, installed, and maintained to prevent contamination of the water supply, food and food utensils, as required by 21 CFR 1250.30(d).
Specifically, the following were observed during the inspection:
a. The vegetable preparation sink was plumbed directly into the sewage drain pipe without backflow prevention.
b. The hand wash sink's drain pipe was plumbed directly into the three compartment sink. To prevent the deposit of effluent into another sink, the hand wash sink should instead be plumbed into a sewage drain pipe with backflow prevention.
c. The three compartment sink was plumbed directly into the sewage drain pipe without backflow prevention.
d. The hot water heater overflow pipe emptied directly into your vegetable preparation sink. The overflow pipe should empty into a floor drain to prevent potential hot water heater sediments from being deposited into the vegetable prep sink.
e. The shut-off valve on an overhead water supply line connected to the hot water heater was leaking. The leakage was being routed via a garden hose to the three compartment sink. The end of the garden hose was below the sink's flood rim.
2. Failure to have an indicating thermometer, suitably located, to permit the determination of the hot water temperature when and where hot water is used as the bactericidal agent, as required by 21 CFR 1250.33(a). Specifically, during our inspection the final rinse temperature gauge on the dish washing machine was not operational.
3. Failure for all food-handling operations to be accomplished in a manner so as to minimize the possibility of contaminating food, drink or utensils, as required by 21 CFR 1250.32(a).
Specifically,
a. An open bucket of sanitizer that exceeded 200 ppm was observed sitting on a table where ready to eat meals were being prepared.
b. An employee was observed using sanitizer that was stronger than the manufacturer's stated instructions of 200 ppm on food contact surfaces, such as a cutting board and knife. The cutting board had ready to eat food sitting on part of it while it was cleaned with the sanitizer.
c. An employee was observed using sanitizer that exceeded 200 ppm and then returned to preparing food without washing his hands.
d. The ceiling over the prep sink was peeling and cracking. FDA observed food being prepared in this sink.
4. Failure to construct and maintain all areas where food is prepared, served, or stored so that they are clean, as required by 21 CFR 1250.30(a). Specifically, the floor around the dish machine, three compartment sink, hand sink and ice machine was dirty and standing water was observed on the floor.
The inspectional observations, identified above, are not intended to be an all-inclusive list of the violations observed at your facility. It is your responsibility to ensure adherence with all requirements of FDA regulations at this facility, and any other facilities involving interstate travel and sanitation under your control. You should take prompt action to correct the violations cited. It is your responsibility to ensure that all requirements of the PHS Act, the Federal Food, Drug, and Cosmetic Act, and their implementing regulations, are being met.
Based on these inspectional findings, a "Provisional" classification bas been assigned to your facility for a 30 day period, after which time a re-inspection will be conducted. A "Provisional" classification means that the facility may continue to operate; however, significant correction of violations must be made. If the conditions of food production and operation of the facility are not improved and verified by FDA by the time of the next inspection, then your facility will be classified as "Use Prohibited" or "Not Approved." Airlines may not obtain their food from a "Use Prohibited" or "Not Approved" source.
You should notify this office in writing, within 15 working days of receipt of this letter, of any additional specific steps you have taken to correct each of the violations. Your response should include a discussion of any delays you foresee in achieving correction, and a deadline by which correction can be expected.
Your response should be sent to the U. S. Food and Drug Administration, Attention: Karen Gale Sego, Compliance Officer, 6751 Steger Dr., Cincinnati, OH 45237. If you have any questions with regard to this letter, you may contact Karen Gale Sego at (513) 679-2700 extension 164 or via e-mail: karen.sego@fda.hhs.gov.
Sincerely,
/S/
Teresa C. Thompson
District Director
Cincinnati District
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