Public Health Service Food and Drug Administration
Atlanta District Office 60 8th St., NE Atlanta, GA 30309
November 23, 2015
VIA UPS OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
Daniel T. Bucaro, President & CEO
Landmark Aviation, LLC
1500 CityWest Boulevard, Suite 600
Houston, TX 77042
Dear Mr. Bucaro,
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 located at 5875 S. Aviation Avenue, North Charleston, SC from "Approved" to "Provisional" for interstate carrier use.
On July 30-31, 2015, the FDA conducted an inspection of your commissary, aircraft servicing area and watering point at your fixed base operation located at 5875 S. Aviation Avenue, North Charleston, SC. This inspection was conducted under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to determine your compliance with the applicable sections of the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food regulations (21 CFR Part 11 0) and 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. The Interstate Conveyance Sanitation 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, the FDA investigator issued a list of Inspectional Observations to your firm. A copy of the FORM FDA 483 is enclosed. We are in receipt of the letter dated August 13, 2015 from Mr. Ben Wells, General Manager, regarding the corrections that have been made in response to inspectional observations documented on the FORM FDA 483. We will verify these corrections during our next inspection. However, the response fails to address the following significant violations under 21 CFR Part 1250, documented on the FORM FDA 483. Based on these violations, your watering point and aircraft servicing area is classified as "Provisional".
To comply with 21 CFR 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 investigator found that there was no back flow prevention (BFP) device in place between the potable water system and the sewer dump hole to protect against contamination of the potable water system. In addition, the water hose used to fill the potable water cart needs to be certified/approved for potable water use.
The inspectional observations, identified above, are not intended to be all-inclusive of the conditions observed at your facility. It is your responsibility to ensure adherence with all requirements of the applicable regulations at all of your domestic Fixed Base Operations with 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 located adjacent to the Charleston International Airport in North Charleston, SC for a 30-day period, after which time are-inspection will be conducted. A "Provisional" classification means that the watering point and aircraft servicing area may continue to operate; however, significant correction of an observed violation must be made. If significant correction is 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 Janice L. King, Compliance Officer at the address noted in the letterhead.
If you have any questions with regard to this letter, please contact Janice L. King, Compliance Officer, at 843-746-2990, x16 or firstname.lastname@example.org.