MN Airlines LLC dba Sun Country Airlines 8/18/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506 Telephone: 949-608-2900 FAX: 949-608-4415

 

 

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

August 18, 2010

W/L 39-10

Mr. Stanley J. Gadek
President and Chief Operating Officer
MN Airlines LLC d/b/a Sun Country Airlines
1300 Mendota Heights Road
Mendota Heights, MN 55120

Dear Mr. Gadek:

Between June 17 and 21, 2010, the U.S. Food and Drug Administration (FDA) conducted an inspection of your airline conveyance facility located at 3835 N. Harbor Drive, Suite 107, Terminal 2, San Diego, California. 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, on June 21, 2010, the FDA investigator issued a list of Inspectional Observations (FDA-483) to your firm. As documented on this form (copy enclosed), the following are the significant violations at your airline conveyance facility:

1. To comply with 21 CFR 1250.27, you must keep all perishable food or drink at or below 50° F, except when being prepared or kept hot for serving. However, perishable food onboard your air conveyance lacked temperature controls necessary for food safety. Specifically, on two separate occasions, foods that were intended for service to passengers on a return flight from San Diego, CA to Minneapolis, MN were held at an unsuitable temperature and were allowed to remain at an elevated temperature for an extended time period during the outbound flight from Minneapolis to San Diego and the layover in San Diego. The flight from Minneapolis to San Diego is approximately 3 hours and 45 minutes and the layover in San Diego is approximately 45 minutes. At minimum, therefore, these foods were held at unsuitable temperatures for more than four hours on each occasion before being served to passengers. The following temperatures were observed in San Diego prior to the return flight:

• On 6/17/10: Cheese Pizza 60°F; Cheeseburgers 65°F; Steak entree with potato and carrots 70-74°F.
• On 6/18/1 0: Cheese Pizza 82-85°F; Cheeseburgers 85°F; Steak entree with potato and carrots 54-57°F.

These foods should be stored under dry ice, or another suitable form of refrigeration, to ensure that the foods are maintained at an appropriate temperature during the outbound flight and prior to service to passengers.

2. To comply with 21 CFR 1250.28, all ice coming into contact with food or drink must be stored and handled in such a manner as to avoid contamination. However, no ice scoops were available for use by flight attendants for dispensing ice for drinks served to passengers during flight 403 from Minneapolis to San Diego on June 17, 2010.

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 this facility, and any other facilities involving interstate travel and sanitation under your control.

You should take prompt action to correct the deficiencies. 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. 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.

Please send your reply to the Food and Drug Administration, Attention: Blake Bevill, Director, Compliance Branch, 19701 Fairchild, Irvine, CA 92612. If you have any questions regarding this letter, please contact Mr. Robert McNab at (949) 608-4409.

Sincerely,
/S/
Director, Los Angeles District
 

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