FDA WARNING_LETTER - Flying Food Group, LLC. - May 14, 2015

An FDA inspection of Flying Food Group, LLC.'s Harbor City, California facility from April 21 to May 14, 2015, revealed significant violations. Environmental samples confirmed the presence of *Listeria monocytogenes* (L. monocytogenes), a human pathogen. Whole Genome Sequencing analysis indicated a persistent strain of L. monocytogenes in the facility since August 2011, demonstrating an inability to eliminate the pathogen and rendering ready-to-eat food products adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Additionally, FDA investigators observed several Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 110. These included failures to construct, handle, and maintain equipment to prevent contamination (21 CFR 110.80(b)(7)); maintain equipment in an acceptable condition through cleaning and sanitizing (21 CFR 110.80(b)(1)); ensure equipment and utensils are adequately cleanable and maintained (21 CFR 110.40(a)); and maintain plant buildings and facilities in a sanitary condition and good repair (21 CFR 110.35(a)). The firm must take prompt corrective actions, investigate causes, prevent recurrence, and provide a written response within fifteen working days detailing specific steps, documentation, and timelines. Failure to comply may result in further FDA action, including product seizure, injunction, and re-inspection fees.