Inspections, Compliance, Enforcement, and Criminal Investigations
American Classic Voyages Co. 16-Jul-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
New Orleans District
6600 Plaza Drive, Suite 400
New Orleans, Louisiana 70127
July 16, 2001
WARNING LETTER 2001 -NOL-38
OVERDRAFT DELIVERYMr. Roderick K. McLeod, President
American Classic Voyages Co.
1380 Port of New Orleans Place
New Orleans, Louisiana 70130
Dear Mr. McLeod:
On June 20, 2001, as part of an illness outbreak investigation, we inspected your interstate passenger cruise vessel, the Mississippi Queen, docked at the Robin Street Wharf, 1380 Port of New Orleans Place, New Orleans, Louisiana. During that inspection, our investigators observed violations of the Public Health Service Act and its implementing regulations (Title 21, Code of Federal Regulation, Part 1240, Control of Communicable Diseases; Part 1250, Interstate Conveyance Sanitation; Part 110, Good Manufacturing Practices; and the Federal Food, Drug, and Cosmetic Act).
At the conclusion of the inspection, the investigators discussed with Mr. David Simmons, Senior Vice President of Hotel Operations, the following sanitation deficiencies that could have contributed to the gastrointestinal outbreak that occurred during the Mississippi Queen Cruise 522, June 13-20, 2001.
(a) Galley workers handling ready-to-eat foods became ill during the cruise. These workers may have contaminated food they handled prior to being relieved of their duties.
(b) Cooking, cooling, and reheating processes of potentially hazardous foods lacked time/temperature monitoring procedures. Without time and temperature monitoring, pathogenic microorganisms and/or toxin production could have contributed to contamination of food.
(c) Cutting boards stored on a shelf below the salad preparation table were soiled with splash from the deck. The cutting boards could have been contaminated by the floor splash and later contaminated foods prepared on them.
Also at the conclusion of the inspection, the investigators presented Mr. Simmons the Form FDA 483 Inspectional Observations. The following violations of Title 21, Code of Federal Regulations, Part 110 were observed:
- No sneeze guards were installed at the passenger buffet station;
- A cockroach was observed on the cutting board storage shelf;
- A package of raw beef was stored above packaged, ready-to-eat ham in a walk-in refrigerator;
- Cutting boards stored on a shelf below the salad preparation table were soiled with splash from the deck;
- The interior food contact services of the soft serve ice cream machine were soiled with ice cream residues; and,
- Surfaces between and under equipment were soiled with food debris.
The above listing of inspectional observations is not intended to be an all-inclusive listing of deficiencies that may have existed. It is your responsibility to assure adherence with all requirements of the regulations.
We are aware that at the conclusion of our inspection, you made a verbal commitment to correct deficiencies and to take steps to prevent further illness. However, you should notify this office in writing, within 15 working days of the receipt of this letter, of the specific steps you have taken to correct the noted violations and to prevent their recurrence. If all corrections cannot be completed before you respond, please explain the reason for the delay and state when you will correct any remaining deficiencies.
Please send your reply to the Food and Drug Administration, Attention: Nicole F. Hardin, at the above address. If you have questions regarding any issue in this letter, please contact Ms. Hardin at (504) 253-4519.
Patricia K. Schafer
Acting District Director
New Orleans District
Web page created by god 7/31/02