FDA EIR - Blue Chip Group, Inc - February 13, 2019

An FDA surveillance inspection of Blue Chip Group, Inc. (BCG), a dried/freeze-dried food manufacturer located in Salt Lake City, UT, was conducted from February 12-13, 2019. The inspection assessed compliance with 21 CFR 117 (Current Good Manufacturing Practices for Human Food) and general food labeling requirements under Compliance Program 7321.005.

Two primary objectionable conditions were identified and detailed in an FDA-483 form issued to CEO Robert S. Conlee. First, the firm failed to implement adequate sanitation principles to prevent allergen cross-contact and contamination, exemplified by employees using a single unwashed scoop for both allergen and non-allergen ingredients, and spilled allergen-containing milk powder near non-allergen products. Second, the company did not ensure reasonable personnel practices; employees were observed touching non-food contact surfaces and then food or food contact surfaces with the same unwashed gloved hands, or wiping their face before handling food.

Management acknowledged these issues and committed to implementing corrective actions within 30 days. These included providing separate scoops, assigning a cGMP monitor, enhancing cleanup procedures, and re-training employees on proper Good Manufacturing Practices. Discussions also covered the need to properly document corrective actions for out-of-range environmental monitoring results and record subsequent passing test values. Mr. Conlee expressed intent to submit a written response to the FDA-483 within 15 business days.