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WARNING LETTER

Aspen Station/Aspen Pitkin County Airport MARCS-CMS 535343 —


Delivery Method:
VIA UPS
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. John Kinney
Recipient Title
Director of Aviation
Aspen Station/Aspen Pitkin County Airport

233 East Airport Rd. Suite A
Aspen, CO 81611
United States

Issuing Office:
Office of Human and Animal Food Operations Division IV West

United States



December 18, 2017

WARNING LETTER


Ref#: HAF4W (DEN)-18-03-WL

Dear Mr. Kinney:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your interstate conveyance support facility located at 27280 E. 75111 Avenue, Denver, Colorado on July 11 and July 12, 2017. This 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 under 21 Code of Federal Regulations Part 1250 (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.

At the conclusion of the inspection on July 12, 2017, our FDA investigators issued a list of lnspectional Observations (FDA- 483) to your firm. As documented on this form (copy enclosed), the following significant violations of 21 CFR Part 1250 were noted at your interstate conveyance support facility:

1. To comply with 21 CFR Part 1250.75(a), disposal operations, at servicing areas and at stations where land and air conveyances are occupied by passengers, shall be conducted so as to avoid contamination of such areas and stations by human wastes. However, our investigators observed "blue" water containing apparent tissue residue overflowing from your human waste disposal holding tank presenting the potential for employee foot traffic and rolling equipment to cross-contaminate other areas of the grounds and facilities.

2. To comply with 21 CFR Part 1250.63, servicing areas shall be provided with all necessary sanitary facilities operated and maintained so as to prevent the spread of communicable diseases. However, our investigators observed that the only available hand-sink was in an airplane hangar approximately 50 feet away from the dump site and is not always open for use.

3. To comply with 21 CFR Part 1250.67, all servicing area piping systems, hydrants, taps, faucets, hoses, and equipment necessary for delivery of drinking and culinary water to a conveyance must be designed, constructed, maintained, and operated in such a manner as to prevent contamination of the water.

However, our investigators observed a water faucet that lacked adequate backflow prevention and was equipped with a non-food grade green garden-type hose, which was located in the small room near the servicing/dump area (TSA Baggage screening room).

In addition, our investigators notified your Director of Airport Operations that all plans for construction or major reconstruction of sanitation facilities at servicing areas shall be submitted to the Commissioner of Food and Drugs at the FDA for review of the conformity of the proposed facilities with the requirements of 21 CFR Part 1250.

To date, we have not received a response from you or associated facility/airline managers describing any corrective actions planned to ensure your servicing areas do not provide a source of contamination or the spread of disease. If the conditions at your 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."

The inspectional observations, identified above, are not intended to be an all-inclusive list of the conditions observed at your facility. 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, Office of Human and Animal Foods Division 4 West, Attention: Nancy G. Schmidt, Compliance Officer, P.O. Box 25087, Denver, CO 80225. If you have any questions regarding this letter, please contact Ms. Schmidt at (303) 236-3046.

Sincerely,
/S/
LaTonya M. Mitchell
Denver District Director
Program Division Director
Office of Human and Animal Food Operations
Division IV West