Quong Hop & Co – FDA Warning Letter, May 4, 2010

On September 2, 2010, the FDA issued a Warning Letter to Quong Hop & Co. following an inspection from April 27 to May 4, 2010, at their South San Francisco facility. The inspection revealed that the company's products were adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions, and their "Raquel's Hummus & Dip Spicy Hummus" product was misbranded under 21 U.S.C. § 343(i) and (q).

Key violations included the detection of *Listeria monocytogenes* in the tofu processing area, indicating a need for enhanced sanitation and environmental monitoring. Significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 110) were identified: mold growth on walls and pipes in the tofu processing room and near the salad room entrance, a recurring issue from previous inspections; inadequate cleaning and sanitizing of equipment for ready-to-eat hummus production, with dried food residue observed; and poor employee hygienic practices, such as direct contact with food using soiled garments and eating/chewing gum in food processing areas. Additionally, metal trays used for tofu production were rusted, cracked, and holed.

The company also violated seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123)