Nam & Nam, Inc. t/a Sam Sung Tofu – FDA Warning Letter, Jun 23, 2015

On December 3, 2015, the FDA issued a Warning Letter to Nam & Nam, Inc. t/a Sam Sung Tofu following an inspection from June 18-23, 2015. The inspection revealed significant violations of Current Good Manufacturing Practices (21 CFR 110) and Food Labeling (21 CFR 101) regulations, rendering their tofu products adulterated and misbranded.

Adulteration violations included: 1. Failure to sanitize manufacturing equipment (21 CFR 110.35(a)). 2. Inadequate toilet facilities, including a non-flushing toilet, used toilet paper in a trash receptacle, and no handwashing sink (21 CFR 110.37(d)). 3. Employees not washing and sanitizing hands after leaving and returning to workstations (21 CFR 110.10(b)(3)). 4. A water leak from the ceiling onto the manufacturing floor near uncovered tofu (21 CFR 110.37(b)(3)). 5. Improper storage of toxic cleaning compounds next to finished tofu product (21 CFR 110.35(b)(2)).

Misbranding violations for their 50-piece, bulk-packaged tofu included: 1. Failure to declare the major food allergen, soy (soybeans), as required by 21 U