FDA WARNING_LETTER - Clasen Quality Coatings, Inc. - June 19, 2007

The FDA inspected Clasen Quality Coatings, Inc.'s facility in Middleton, Wisconsin, from May 29 to June 19, 2007, and found significant deviations from Current Good Manufacturing Practice (cGMP) regulations (21 CFR Part 110). These violations render the firm's food products adulterated under 21 U.S.C. 342(a)(4) due to insanitary conditions.

Specifically, the inspection revealed: 1. **Inadequate Cleaning (21 CFR 110.35(d)):** Food contact surfaces, including equipment and piping, were not cleaned with sufficient frequency. The firm only scraped or brushed readily available surfaces and flushed only one set of pipes, leaving significant product residue. Up to [redacted] lbs. of milk protein-containing product remained in bulk liquid tanks when non-milk products were loaded. 2. **Insufficient Production Procedures to Prevent Contamination (21 CFR 110.80):** The firm's cleaning and production sequencing procedures were inadequate. No tests were conducted to demonstrate cleaning adequacy, despite visible milk traces after cleaning. Internal testing in April 2007 found milk protein in all [redacted] non-dairy ingredient product samples. No additional samples or corrective actions were taken. The firm also failed to sequence production (e.g., running non-dairy products before dairy products) to minimize cross