| Public Health Service Food and Drug Administration |
| PHILADELPHIA DISTRICT 900 U.S. Customhouse 2nd and Chestnut Streets Philadelphia, PA 19106 Telephone: 215-597-4390 |
Department of Health and Human ServicesWARNING LETTER
10-PHI-10
DELIVERED BY HAND
August 25, 2010
Wesley W. Heerssen, Jr., Master
Flagship Niagara League, Inc.
150 E. Front Street
Erie, Pennsylvania 16507
Dear Mr. Heerssen:
In July 2010, Erie County Department of Health officials reported an outbreak of Salmonella serotype Enteritidis (SE) on board your passenger vessel, Flagship Niagara, when the vessel was located near Cleveland, OH on July 10-11, 2010. Their investigation of the outbreak concluded that the ill individuals ate food items that were served on board your vessel, including a Mexican chicken diner and macaroni salad that contributed to the outbreak.
Subsequently, on July 17 and 19, 2010, the U.S. Food and Drug Administration (FDA) conducted an inspection of your passenger vessel, located at that time at 150 E. Front Street, Erie, Pennsylvania, which operates in interstate waters between its home port in Erie, Pennsylvania and various locations in the Great Lakes, including Cleveland, Ohio, Chicago, Illinois, and Duluth, Minnesota. 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 U.S.C. 264). Regulations promulgated under this section are necessary to prevent the introduction, transmission, or spread of communicable diseases. This inspection revealed significant deviations from 21 CFR Part 1250, under the PHS Act.
At the conclusion of the inspection, the FDA investigator issued a list of Inspectional Observations (Form FDA-483) to you. As documented on this form (copy enclosed), the following are the significant violations noted on your passenger vessel:
1. Your passenger vessel does not have water available at adequate temperatures, to all rooms in which food is prepared and utensils are cleaned, as required by 21 CFR 1250.30(c). Specifically, there is no hot water available on your ship for hand washing and cleaning purposes.
2. Your passenger vessel does not have a refrigerator that is equipped with a thermometer located in the warmest portion thereof, as required by 21 CFR 1250.34. Specifically, a thermometer was not installed in the (b)(4) brand reach-in refrigerator located in the ship's galley.
3. Your passenger vessel does not store all utensils used in connection with the preparation, storage, and serving of food or beverages so as to prevent contamination before reuse, as required by 21 CFR 1250.33(c). Specifically, clean pots and pans were stored on the floor of the ship's galley. Storage of these items directly on the floor of the galley does not adequately prevent contamination of these items before use.
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 assure adherence with all requirements of the regulations at this facility, and any other facilities involving interstate travel and sanitation under your control.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to enjoin your passenger vessel from operating. 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.
In addition, FDA recommends that the person in charge of your vessel, and your ship's cook, be trained in safe food-handling practices, such as properly cooking and cooling potentially hazardous food.
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.
Your response should be sent to Lynn S. Bonner, Compliance Officer, at the address noted above. If you have any questions with regard to this letter, Ms. Bonner can be reached at 215-717-3074 or Lynn.Bonner@fda.hhs.gov.
Sincerely,
/s/
Kirk D. Sooter
District Director
Philadelphia District Office
Enclosure: Form FDA 483
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