FDA WARNING_LETTER - Happy Sprout Inc. - July 08, 2022

On October 27, 2022, the FDA issued a Warning Letter to Ms. Lee, owner of a sprouting operation at 7954 Twist Lane, Unit H, Springfield, VA. This letter followed an inspection from May 23-26, 2022, and July 8, 2022, which revealed serious violations of the Produce Safety Regulation (21 CFR Part 112). The FDA determined that the firm's mung bean and soybean sprout products were adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations included: 1. **Lack of Environmental Monitoring Plan:** No written plan for Listeria species or *Listeria monocytogenes* testing, despite FDA finding Listeria species in environmental swabs and a finished product sample. This was a repeat violation from 2019. The firm's response was inadequate as it lacked a procedure, plan, or timeframe. 2. **No Pathogen Testing Plan for Spent Sprout Irrigation Water (SSIW) or In-Process Sprouts:** The firm admitted to not sampling SSIW or in-process sprouts for pathogens like *E. coli O157:H7* or *Salmonella spp.* This was also a repeat violation. The firm's response lacked a testing plan or evidence of implementation. 3