FDA WARNING_LETTER - Blue Heron Bakery - February 01, 2018

The FDA inspected Blue Heron Bakery in Olympia, Washington, on November 28-December 6, 2017, and January 25-February 1, 2018, observing serious violations of cGMP regulations (21 CFR Part 110). The firm's food products were deemed adulterated under section 402(a)(4) of the Act due to insanitary conditions.

Key violations included: 1. **Failure to exclude pests (21 CFR 110.35(c)):** Extensive rodent excreta pellets (REPs) were found in production and storage areas, including near mixers, dough rollers, dry ingredient racks, under carts storing clean pans, and behind dishwashers. An FDA sample confirmed rodent activity. Similar conditions were noted in the previous inspection. 2. **Inadequate pest protection (21 CFR 110.20(b)(7)):** The rear exterior door was propped open daily without pest prevention. 3. **Failure to wear hair restraints (21 CFR 110.10(b)(6)):** Two employees with facial hair worked in production without beard covers or hair nets, a repeat observation. 4. **Improper storage of personal belongings (21 CFR 110.10(b)(7)):** Employee coats, uncovered beverages, and personal food items were observed