Landmark Aviation – FDA Warning Letter, Jul 31, 2015

The FDA conducted an inspection of Landmark Aviation's watering point and aircraft servicing area in North Charleston, SC, on July 30-31, 2015. As a result, the facility's classification was changed from "Approved" to "Provisional" for interstate carrier use. The inspection assessed compliance with Current Good Manufacturing Practice (21 CFR Part 110) and Interstate Conveyance Sanitation regulations (21 CFR Part 1250, 21 CFR Part 1240) under the FD&C Act and PHS Act. The firm's response to the FORM FDA 483 failed to address significant violations under 21 CFR Part 1250. Specifically, investigators found no backflow prevention device between the potable water system and the sewer dump hole, and the water hose used for the potable water cart was not certified/approved for potable water use. These deficiencies violate 21 CFR 1250.67, which mandates proper design, construction, maintenance, and operation of water delivery systems to prevent contamination. The "Provisional" classification is for a 30-day period, after which a re-inspection will occur. The firm must notify FDA within fifteen working days of specific corrective actions and provide documentation. Failure to make significant corrections will lead to a "Non-Approved" classification, prohibiting interstate carriers from using the facility for potable water or servicing, as required by 21 CFR 1240.80 and 21 CFR 1250.60.