FDA WARNING_LETTER - Dressel Farms, LLC - November 14, 2012

The FDA inspected Dressel Farms, LLC's juice processing facility from October 31 to November 14, 2012, and found serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120). These violations render their apple cider adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Monitoring Procedures:** The HACCP plan's monitoring procedures for patulin at the sorting, washing, and culling critical control point (visual checks for internal/external rot) do not ensure compliance with the 50 ppb patulin critical limit. 2. **Failure to Implement Monitoring Procedures:** The firm did not follow its HACCP plan's monitoring procedures for patulin, only monitoring (b)(4) apples per day despite processing up to (b)(4) bushels daily. 3. **Missing Critical Control Point:** The HACCP plan lacks a critical control point for the identified metal hazard from processing equipment. Additionally, cracked and splintered wood used for pressing apples was observed, posing a physical hazard, and no monitoring records for screens/filters were maintained. 4. **Deficient Corrective Actions:** The corrective action for the "sorting, washing, and culling" critical control point does not ensure the cause of deviation is corrected or that adulterated