FDA WARNING_LETTER - Korean Food, Inc. - August 25, 2023

The FDA inspected a sprout and kimchi production facility in Irving, Texas, from August 21-25, 2023, revealing serious violations of the Produce Safety Rule (21 CFR Part 112) and Food Labeling regulations (21 CFR Part 101). The soybean sprouts were deemed adulterated under 21 USC § 342(a)(4) due to insanitary conditions, and kimchi products were misbranded under 21 U.S.C. § 343(a)(1).

Key violations include: 1. **No Environmental Monitoring Plan:** Failure to establish and implement a written environmental monitoring plan for *Listeria* species or *Listeria monocytogenes* (21 CFR 112.145). 2. **Inadequate Sprout Sampling Plan:** Failure to establish and implement a written sampling plan for spent sprout irrigation water (SSIW) or sprouts for each production batch, and not testing for *E. coli O157:H7* (21 CFR 112.147, 21 CFR 112.144(b)). 3. **Improper Cleaning and Sanitization:** Failure to clean and sanitize food contact surfaces used for sprouts before contact (21 CFR 112.143(b)). 4. **Inadequate Drainage and Facility Maintenance