FDA WARNING_LETTER - golden crown bakery, inc. - February 04, 2014

On January 27-31 and February 4, 2014, the FDA inspected a food manufacturing firm at 12310 Highway 99, Units 115-117, Everett, Washington. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food, 21 CFR Part 110, causing food products to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Laboratory analysis of sample 788645 confirmed the presence of rodent excreta pellets (REPs) in the first-floor production room and Tribolium confusum (confused flour beetles) in the production mezzanine where ingredients were stored.

Significant violations included: 1. Failure to exclude pests and protect food from contamination (21 CFR 110.35(c)): Evidence of extensive rodent activity (at least 550 REPs) and live/dead insects was found throughout the facility, including on/near freshly baked bread, in-process dough, and ingredients. Specific observations included REPs in baking pans, on floors near food, on racks storing uncovered bread, and near a homemade rodent trap containing decaying rodents. Live insects were found on ingredient boxes and packaging materials. 2. Failure to provide adequate pest screening/protection (21 CFR 1