FDA WARNING_LETTER - W. H. Walker Sons Inc - September 26, 2012

The FDA inspected W.H. Walker & Sons, Inc.'s juice processing facility in Clintondale, NY, on September 13, 21, and 26, 2012, finding serious deviations from 21 CFR Part 120 (juice HACCP regulation) and misbranding under Section 403(i)(2) of the Act.

Violations include: 1. **Failure to take corrective action for critical limit deviations:** Pasteurization records for apple cider from September and October 2011 showed temperature drops below the critical limit of (b)(4)°F for (b)(4) seconds, but no corrective action was taken to control *Cryptosporidium parvum*. The firm's response was inadequate as it did not follow its HACCP plan's corrective action to segregate and re-pasteurize affected products, and the provided scientific basis was insufficient for *Cryptosporidium parvum*. 2. **Inadequate HACCP plan monitoring procedures:** The HACCP plan for apple cider's culling critical control point, designed to prevent patulin with a critical limit of less than (b)(4)% rotten fruit, listed an inadequate monitoring procedure ("(b)(4)"). The firm also failed to measure or maintain records demonstrating compliance with this critical limit. The firm's revised HACCP plan and promised corrective actions were deemed insufficient due to lack of implementation evidence and continued absence