FDA WARNING_LETTER - P&L Bean Sprout Farm - March 12, 2024

The FDA inspected a sprouting operation in Cochranville, Pennsylvania, from January 31 to March 12, 2024, identifying serious violations that render mung bean and soybean sprout products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Key observations included gray sludge contaminating sprouts, apparent rodent excreta near packaging, and structural deficiencies such as peeling paint, cobwebs, and a wet, cracked floor in the processing area. Investigators also noted a frayed hose stored on the floor and used without cleaning, and an employee exhibiting poor glove hygiene. Furthermore, a poorly maintained exit door allowed pest entry, and harborage conditions existed around the facility's perimeter. Many of these issues, including pest control, building maintenance, and employee handling, were repeat observations from a previous inspection in March 2023. The firm's proposed corrective actions were deemed insufficient or lacked documentation. The letter reminds the firm of its eligibility for a qualified exemption under 21 CFR Part 112 (Produce Safety Rule) but warns of potential withdrawal if public health is at risk. The firm must respond within fifteen working days, detailing specific corrective actions, recurrence prevention, and supporting documentation, or face potential legal action.