AFP advanced food products LLC – FDA Warning Letter, Jul 11, 2013

The FDA conducted an inspection of AFP Advanced Food Products LLC's aseptic manufacturing facility in Clear Lake, Wisconsin, from June 24-28 and July 11, 2013. The facility processes and packages low-acid canned foods (LACF) and acidified products, including nutritional drinks, puddings, cheese sauces, chilis, dips, and salsas.

The inspection revealed significant deviations from the Low-Acid Canned Foods (LACF) regulations, 21 CFR Part 113.

**Violations and Deficiencies:**

1. **Failure to equip product sterilizers with accurate temperature-indicating devices (21 CFR 113.40(g)(1)(i)(A)(4)):** The digital temperature-indicating device used as the reference thermometer for multiple aseptic processors from April 4, 2010, to June 24, 2013, had an accuracy of (b)(4) ?F, which is outside the required 1?F or 0.5?C. Additionally, the (b)(4) thermocouple feeding these devices had standard limits of error of (b)(4) ?F or (b)(4) %. The firm's response was deemed inadequate as it misidentified the reference device and mirrored a previous inadequate response from October 2012 for the same observation.

2. **Failure to ensure temperature recording chart