Kaiser Air Inc 3/24/14
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone: (510) 337-6700
Delivery Signature Requested
March 24, 2014
Ronald J. Guerra, President
8735 Earhart Rd.
Oakland, CA 94621-4547
Dear Mr. Guerra:
This letter serves as your formal notification that the U.S. Food and Drug Administration (FDA)has changed the classification of your watering point and aircraft servicing area from “Approved” to “Provisional” for interstate carrier use.
On November 21 through 22, 2013, the FDA conducted an inspection of your aircraft servicing area and watering point located at your executive jet terminal, 8735 Earhart Road, Oakland, 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), in accordance with 21 CFR Part 1240. 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 violations of 21 CFR Part 1250, under the PHS Act. Based on these findings, your watering point and aircraft servicing area is classified as “Provisional.”
At the conclusion of the inspection, the FDA investigator issued a list of Inspectional Observations (Form FDA-483), and an Inspection Summary – Airline Service Area or Watering Point Sanitation (Form FDA 2528) to your firm (copies attached). As documented on the Form FDA-483, the following are the significant violations on which we base the “Provisional” classification:
1. To comply with 21 CFR 1250.67(a), all servicing area piping systems, hydrants, taps, faucets, hoses, buckets, and other 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. However, our investigator found that there is no back flow prevention device in place between the potable water system and the lavatory sanitizer/deodorizing solution to protect against contamination of the potable water system. In addition, the water hose used to fill the potable water cart is made of non-food grade material.
2. To comply with 21 CFR 1250.63, servicing areas must be provided with all necessary sanitary facilities so operated and maintained as to prevent the spread of communicable diseases. However, our investigator observed toilet paper and other trash debris adjacent to the lavatory dump station. Ground crew employees were observed walking through the fecal waste materials. These same employees were observed providing customer services inside the executive air terminal, aboard aircrafts during cleaning and meal delivery, performing aviation repairs in the hangars, and eating in the lunchroom.
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 your aircraft servicing areas and watering points, and any other conveyances or facilities involving interstate travel and sanitation under your control.
Based on these inspectional findings, a “Provisional” classification has been assigned to your watering point and aircraft servicing area for a 30-day period, after which time a re-inspection will be conducted. A “Provisional” classification means that the watering point and aircraft servicing area may continue to operate; however, significant correction of violations must be made. If significant corrections are not made by the time of the next inspection, FDA will reclassify the watering point and aircraft servicing area as “Non-Approved” for carrier use. We note that land and air conveyances engaged in interstate travel must obtain potable water for drinking and culinary purposes from watering points approved by FDA (21 CFR 1240.80) and must use servicing areas that have been approved by FDA (21 CFR 1250.60).
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct the violations described above. Include in your response documentation to show correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and when you will complete the corrections.
Your response should be sent to:
Lawton W. Lum
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
If you have any questions with regard to this letter, please contact Brandon Bridgman, Compliance Officer, at 510-337-6794 or Brandon.Bridgman@fda.hhs.gov
Kathleen M. Lewis, J.D.
San Francisco District Office
Ms. Deborah Ale Flint, Executive Director
Port of Oakland- Airport Division
530 Water Street
Oakland, CA 94607