FDA WARNING_LETTER - Kaiser Air Inc - November 22, 2013
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On March 24, 2014, the FDA issued a Warning Letter to Kaiser Air, classifying their watering point and aircraft servicing area as "Provisional" for interstate carrier use. This reclassification followed an inspection conducted on November 21-22, 2013, at their Oakland, California facility, under the Public Health Service Act (PHS Act) and 21 CFR Part 1250 and 1240.
The inspection revealed significant violations of 21 CFR Part 1250. Specifically, 21 CFR 1250.67(a) was violated because no backflow prevention device was in place between the potable water system and the lavatory sanitizer/deodorizing solution, and the water hose for the potable water cart was non-food grade. Additionally, 21 CFR 1250.63 was violated as toilet paper and trash debris were observed near the lavatory dump station, with ground crew employees walking through fecal waste and then providing customer services, cleaning aircraft, performing repairs, and eating in the lunchroom.
A "Provisional" classification means operations can continue for 30 days, after which a re-inspection will occur. Failure to make significant corrections will result in a "Non-Approved" classification, preventing land and air conveyances from obtaining potable water or using servicing areas from Kaiser Air. Kaiser Air must notify the FDA in
- Company
- Kaiser Air Inc
- Inspection Date
- November 22, 2013
ID · f78d734c-8667-4396-9a73-da21e9d8d528
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