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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Universal Enterprises Inc dba Air Service Hawaii 20-Dec-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510/337-6700


December 20, 2007

WARNING LETTER AND
NOTICE OF PROVISIONAL STATUS

VIA FEDERAL EXPRESS

Our Reference : 3003672104

Charles Gregory Evans, President
Universal Enterprises Inc.
dba Air Service Hawaii
8787 Tallyho Road
Houston, Texas 77061-3420

Dear Mr. Evans:

This letter serves as your formal notification that the U.S. Food and Drug Administration (FDA) has classified your watering point and service area as "Provisional."

On September 18, 2007, investigators from the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, consisting of an aircraft watering point, lavatory waste service area, and commissary located at the Honolulu International Airport. 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 USC 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. Based on these findings, your watering point and service area is classified "Provisional."

The following are the significant conditions at your watering point and service area, on which we based the "Provisional" classification:

1. You must conduct operations in a manner to avoid contamination of areas and stations by human wastes, as required by 21 CFR 1250.75(a). However, our investigators found that you dispose of the human wastes via a [redacted] from the building that is in the direct footpath for crew members. This poses a potential for contamination due to foot traffic of the crew members. Further, you do not have pressurized water to thoroughly clean the area of any spilled sewage to prevent crew members from cross-contaminating either directly or indirectly, the common areas in the airport with tracked spilled sewage. Sewage contains many pathogenic microorganisms, and pathogenic microorganisms from the disposal area could be transferred to food and food contact surfaces via people or vectors such as flies. We recommend that the disposal area contain an impermeable pad that is sloped to a sanitary sewer.

2. All servicing areas, piping systems, hydrants, taps, faucets, hoses, buckets, and their appurtenances necessary for delivery of drinking culinary water to a conveyance must be designed, constructed, maintained, and operated in such a manner as to prevent contamination of the water, to comply with 21 CFR 1250.67(a). Additionally, equipment that is used for flushing waste carts shall be designed to prevent backflow into the waterline , and such equipment shall be used for no purpose connected with the handling of water, as required under 21, CFR 1250.75(b). However, our investigators found that the water line used to fill the potable water cart is also used to flush the [redacted], and failed to have a backflow device as is required for equipment used to flush [redacted]. In addition, the hose was found to be dirty, cracked, and not capped to prevent contamination of the potable water system.

3. At servicing areas the operations shall be conducted so as to avoid contamination of such areas and stations by human wastes, as required by 21 CFR 1250.75(a). However, our investigators observed that the lavatory waste hose was not capped or connected to the lavatory cart when not in use. Human waste spillage from an uncapped lavatory hose could contaminate crew and passengers directly or be transported into the food servicing areas.

A list of Inspectional Observations (FDA-483) was issued to, and discussed with, Robert Morris, Vice President on September 20, 2007. A re-inspection will be made to determine if the future classification of your watering point and service area will be "Approved" or "Not Approved." FDA notes that land and air conveyances engaged in interstate traffic shall use only such servicing areas 'within the United States as have been approved by the FDA (21 CFR 1250.60) and must obtain potable water for drinking and culinary purposes from watering points approved by the FDA (21 CFR 1240.80).

You should notify FDA in writing, within fifteen (15) days of receipt of this letter, stating specific steps you have taken to correct the aforementioned violations including an explanation of each step being taken to prevent the occurrence of similar violations. Your reply should be directly to Marshalette O. Edwards, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions, please contact Marshalette O. Edwards at 510.337.6794.

Sincerely,

Barbara J. Cassens
District Director