FDA WARNING_LETTER - Mountain Laurel Log Homes and Land, Inc. dba Kickin Mule - April 10, 2013

On April 4-10, 2013, the FDA inspected Kickin' Mule's acidified food manufacturing facility in Hiawassee, GA, revealing serious violations of 21 CFR Part 108 (Emergency Permit Control) and Part 114 (Acidified Foods). This rendered their products adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Failure to File Scheduled Processes (21 CFR 108.25(c)(2)):** The firm did not file scheduled processes for Kickin' Mule Olde South Salsa, Spicy Chow Chow, and Southern Delight, despite being identified as acidified foods. Other products like wing and barbecue sauces also lacked process authority evaluation. A submitted registration form (FDA 2541) and promise to file were not fulfilled as of August 21, 2013. 2. **Failure to Manufacture According to Scheduled Process (21 CFR 114.80(a)(1)):** Production records for "Kickin' Mule Olde South Salsa" showed cook temperatures and pH levels deviating from the approved scheduled process. Manufacturing procedures for "Kickin' Mule Southern Delight" also did not match the approved process. 3. **Inadequate Processing and Production Records (21 CFR 114.100(b)):