FDA WARNING_LETTER - King of Pops - June 14, 2017

On June 12-14, 2017, the FDA inspected King of Pops, LLC's ice pop manufacturing facility in North Charleston, SC, and found serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These violations, including active rodent activity, render products adulterated under 21 U.S.C. § 342(a)(4).

Key violations included: 1. **Pest Exclusion Failure (21 CFR 110.35(c)):** Evidence of significant rodent and insect activity, including numerous rodent excreta pellets (REPs) in production areas and raw ingredient storage, and live fly-like insects on food contact surfaces. The firm's response was deemed inadequate due to lack of evidence of effectiveness. 2. **Inadequate Cleaning and Sanitizing (21 CFR 110.35(a)):** Residual food debris observed on production equipment. The firm's corrective action of removing clutter was deemed unclear and inadequate. 3. **Facility Construction and Maintenance (21 CFR 110.20(b)(4)):** Pitted, peeling, and cracked floors in the production room, with standing water and accumulated debris. The firm's response about future re-sealing was inadequate, lacking evidence and a timeframe. 4. **Improper Glove Handling (21