Inspections, Compliance, Enforcement, and Criminal Investigations

BB Riverboats Inc 11/23/16

 

  

Black HHS-Blue FDA Logo

 

 

 
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2775 

 

November 23, 2016
Via United Parcel Service
 
WARNING LETTER
CIN-17-501720-02
                                   
David A. Bernstein, President/Owner
BB Riverboats Inc.
101 Riverboat Row
Newport, KY 41071-1069
 
Dear Mr. Bernstein:
 
This letter serves as your formal notification that the U.S. Food and Drug Administration (FDA) has changed the classification of your Landing’s Galley caterer located at 101 Riverboat Row, Newport, KY 41071-1069 from "Approved" to "Provisional" for interstate carrier use.
 
On June 29-30, July 6 and July 11, 2016, the FDA conducted an inspection of your passenger vessel, caterer, watering point, and service area at your fixed base operation located at the aforementioned address. This inspection was conducted under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to determine your compliance with the applicable sections of the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulations (21 CFR Part 110) and 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), in accordance with 21 CFR Part 1240.  The Interstate Conveyance Sanitation regulations were promulgated pursuant to Section 361 of the PHS Act (42 U.S.C. 264).  Regulations promulgated under this section are necessary to prevent the introduction, transmission, or spread of communicable diseases.
 
At the conclusion of the inspection, the FDA investigator issued a list of Inspectional Observations to your firm. We acknowledge your firm’s response to the Form FDA-483 dated July 18, 2016; these reported corrections will be evaluated during a subsequent inspection of your firm. As documented on the Form FDA-483 dated July 11, 2016, the following are the significant deviations from 21 CFR Part 1250, under the PHS Act, found on your passenger vessels (specifically, the Belle of Cincinnati and River Queen):
 
Your significant Interstate Conveyance Sanitation violations include:
 
1.    Your passenger vessels do not have adequate food handling operations to minimize the possibility of contaminating food, drink, or utensils as required by 21 CFR 1250.32(a). Specifically,
 
a)  On the River Queen:
i.  Employees were observed wearing gloves and touching their clothing and then handling beverage garnishes without changing their gloves; bussing soiled ware from tables and then scooping ice for beverages and preparing ready to eat foods without washing hands; and dumping a cutting board into the trash can that was later used to slice limes and lemons.
ii.  The passenger buffet service was not continuously monitored by an employee trained in safe operating procedures and does not have sneeze guards, packaging, or other effective means to protect the self-service buffet from possible contamination. 
  
b)  Apparent old food residue was observed on non-food contact surfaces of all equipment located throughout the galleys and bars of the Belle of Cincinnati and River Queen.
 
c)  On the Belle of Cincinnati:
i.  Skillets and stainless steel pots were stored in locations soiled with apparent filth, rust, and old food particles.
 
d)  Various food items, including soft drinks, beer, water, drink mixers, and frozen foods, were stored on decks throughout your passenger vessels.
 
2.    Your passenger vessels’ utensils and working surfaces used in connection with the preparation, storage, and serving of food or beverages are not able to be easily cleaned or kept in good repair, as required by 21 CFR 1250.33(a). Specifically,
 
a)  In the Belle of Cincinnati galley:
i.  Numerous pieces of equipment including deep frying baskets, utensils, hot dog holding boxes, a manual can opener, hotel pans and frying pans had apparent old food residue and had not been cleaned properly.
 
b)  In the Belle of Cincinnati bars:
i.  Apparent black mold was found on and in the deck mounted ice machine bin in the deck one bar pantry, inside the (b)(4) floor mounted ice machine in the deck three bar pantry, and in all margarita mixer chutes and chute brackets.
ii.  Apparent old food residue and grease deposits were observed on the food storage areas of the hot box on deck two.
 
c)  In the River Queen galley:
i.  Apparent pink mold was observed on the lower portion of the plastic ice deflector panel to the (b)(4) ice machine. Also, apparent pink mold was on the interior components and surfaces around the evaporator panel.
 
d)  In the River Queen bars and gift shop:
i.      Margarita mixers, ice wells, garnish trays, and ice cream scoops were observed to be soiled.
 
3.    Areas where food is prepared, served, or stored shall be clean and free from flies, rodents, and other vermin as required by 21 CFR 1250.30(a). Specifically,
 
a)  Apparent flies were observed flying and landing around the dishwashing machine and on food contact equipment in the Belle of Cincinnati galley, as well as an apparent dead insect observed in one of the deep fat fryer wells.  
b)  Apparent flies were flying and landing on food service equipment in the River Queen’s galley.
c)  Heavy build-up of debris and old food residue was observed in hard to reach areas under and behind equipment throughout every food service outlet on your passenger vessels.
d)  A substantial amount of old frying oil covered the metal structural components to the deep fat frying unit as well as the bulkhead and deck around and below the unit located in the Belle of Cincinnati’s galley.
 
4.    There shall not be backflow or cross contamination between potable water systems and any other systems, as required by 21 CFR 1250.82(e). Specifically,
 
a)  On the River Queen, a direct connection exists between the vessel's potable water supply and A/C cooling and heating systems without backflow protection. This connection is located in the engine room near the potable water tank.
 
Your significant cGMP violations include:
 
5.    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)  In the Landing’s galley:
i.  The ice machine had apparent red and black mold growth on the water return bath hose and internal surfaces located inside the technical compartment. These surfaces were in contact with water used to manufacture ice used in beverage service. Apparent old food residue was found on a manual can opener, meat slicer, on the mixing head of the floor and counter mounted (b)(4) mixers, and on the portable chopper unit.
 
b)  Employees were observed taking temperatures of cooked chicken with thermometers in which the thermometer stems were not sanitized prior to probing the chicken.
 
6.    All persons working in direct contact with food, food-contact surfaces, and food-packaging materials do not 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,
 
a)  Employees were observed preparing and cutting raw chicken and not changing gloves prior to touching food service equipment, handling clean dishware after touching body parts and dirty counters without washing hands, touching body parts prior to handling ready-to-eat foods, and not wearing proper hair and beard restraints in the Landing galley.
 
7.    All food manufacturing, including packaging and storage, is not conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms or for the contamination of food, as required by 21 CFR 110.80(b)(2). Specifically,
 
a)  Your firm is not following procedures to ensure proper cooling temperatures are met during the cooling process.
b)  Several open or cooked items stored in the Landing’s walk-in and reach-in coolers were not identified with a seven day discard label.
 
8.    Personnel responsible for identifying sanitation failures or food contamination do not have a background of education or experience to provide a level of competency necessary for production of clean and safe food as required by 21 CFR 110.10(c). Specifically,
 
a)  The food safety and sanitation training modules that were developed in response to the previous FDA inspection have not been provided to food handling employees during this operational season that began in March of this year.
 
9.     Non-food-contact surfaces of equipment used in your food operation are not cleaned as frequently as necessary to protect against the contamination of food, as required by 21 CFR 110.35(d)(3). Specifically,
 
a)  Apparent old food residue was observed on non-food-contact surfaces of all equipment in the Landing galley and bars.
 
10.  Your buildings, fixtures, and other physical facilities are not maintained in a sanitary condition or kept in repair sufficient to prevent food from becoming adulterated within the meaning of the Act, as required by 21 CFR 110.35(a). Specifically,
 
a)  Heavy build-up of debris and apparent old food residue was observed in hard to reach areas under and behind equipment throughout the Landing galley, bar, and ice machines.
b)  Standing water covered the deck along the bulkhead behind the 3-compartment sink and grease trap in the dishwasher area of the Landing’s galley. A steady water leak was observed from a pipe to the 3-compartment sink that was contributing to the water build-up. 
 
11.    Sanitizing agents are not adequate under conditions of use, as required by 21 CFR 110.35(d)(5). Specifically,
 
a)  The firm's dishwashers are hot water sanitizing units, and do not have a method in place to ensure the dishwashers are providing an effective heat sanitizing treatment.
b)  The Landing’s (b)(4) flight-type dishwasher does not have a functioning final rinse pressure gauge; employees were observed using the dishwasher to wash soiled ware without proper internal curtains to separate the different ware wash compartments.
 
12.     Cleaned and sanitized portable equipment with food contact surfaces and utensils are not stored in a location and manner that protect from contamination, as required by 21 CFR 110.35(e). Specifically,
 
a)  Apparent filth, old food residue and dust were observed on wire storage racks used to hold previously sanitized hotel pots and pans, as well as on the underside and support arms to the cook line’s stainless steel preparation tables with unprotected deli papers, hotel pans and closed bins of sugar and flour stored below.
 
13.    Cleaning and sanitizing of utensils and equipment is not conducted in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 110.35(a). Specifically,
 
a)  An employee was observed spraying bleach solution onto the floor which also landed on clean dishware stored on a low shelf near the dishwashing area.
 
The inspectional observations identified above are not intended to be an all-inclusive list of the conditions observed at your facility. It is your responsibility to ensure adherence with all requirements of the regulations at your servicing areas and watering points, and any other conveyances or facilities involving interstate travel and sanitation under your control.
 
Based on these inspectional findings, a "Provisional" classification has been assigned to your Landing’s Galley facility for a 30-day period, after which time a re-inspection will be conducted. A "Provisional" classification means that the vessel, caterer, watering point, and service area may continue to operate; however, significant corrections of observed violations must be made. If significant correction is not made by the time of the next inspection, FDA will reclassify the vessel, caterer, watering point, and service area as "Non-Approved".
 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct the violations described above. Include in your response documentation to show correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and when you will complete the corrections.
 
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 to your Landing’s Barge facility.
 
Your response should be sent to the U.S. Food and Drug Administration, Attention: Allison M. McGloin, Compliance Officer, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions with regard to this letter, you may contact Allison M. McGloin at 513-679-2700 extension 2123 or via
 
 
  
Sincerely,
/S/ 
Steven B. Barber
Cincinnati District Director

Page Last Updated: 11/28/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English