FDA WARNING_LETTER - Sun Sen Co., Inc. - April 11, 2022

The FDA inspected a sprout growing, harvesting, packing, and distributing facility at 290 Commerce Circle, Sacramento, California, from March 28-30, 2022, and April 11, 2022. The facility is a farm mixed-type operation subject to the Produce Safety Regulation (21 CFR Part 112) and the CGMP & PC rule (21 CFR Part 117).

The inspection revealed serious violations of the Produce Safety Regulation, leading to the determination that alfalfa and clover sprout products are adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Failure to comply with the PSR is also a prohibited act under section 301(vv). The firm did not respond to the Form FDA 483.

Key violations include: 1. Failure to establish and implement a written environmental monitoring plan for *Listeria* species or *Listeria monocytogenes*, a recurring issue since 2018. 2. Failure to take required actions after *Listeria seeligeri* was identified in environmental samples from a sprout wash tank joint surface. Proposed corrective actions were deemed insufficient. 3. Failure to establish and implement a written sampling plan for spent sprout irrigation water (SSIW) or in-process sprouts, a recurring issue since 2018. 4. Failure