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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Bradley Pacific Aviation, Inc. 17-Oct-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


WARNING LETTER AND
NOTICE OF PROVISIONAL STATUS

VIA FEDERAL EXPRESS

October 17, 2007

Our Reference: 3005292583

Robert W. Yosaitis
President
Bradley Pacific Aviation, Inc.
100 Kaulele Place Suite 200
Honolulu, Hawaii 96810

Dear Mr. Yosaitis,

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 July 7, 2007, an investigator 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 Kahului 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, under the PHS Act. 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 investigator found that you dispose of human the wastes [redacted] of crew and passengers. Further, you do not have water under pressure to clean the area of any spilled sewage that could contaminate crew and passengers directly or be tracked around the common areas in the airport. Sewage contains many disease causing microorganisms, and microorganisms from the disposal area could be transferred to food and food contact substances by people or flies. We recommend that the disposal area contain an impermeable pad sloped to a sanitary sewer.

2. All servicing areas, piping systems, hydrants, taps, faucets, hoses,buckets, and their appurtenances 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, to comply with 21 CFR 1250.67(a). However, our investigator found that the water line used to fill the potable water cart failed to have a backflow device to prevent possible contamination of the potable water system.

A list of Inspectional Observations (FDA-483) was issued to, and discussed with, John N. Adoja, Corporate Line Service Supervisor on July 7, 2007. A copy of the FDA-4B3 is enclosed for your reference. You should also note that an FDA-483 issued to Bradley Pacific Aviation Inc., Kahului International Airport, on August 7, 2006 contained the same observations included in this Warning Letter.

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 directed 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,

/S/

Barbara J. Cassens
District Director