FDA WARNING_LETTER - Sunrise Orchards Inc - October 19, 2010

The FDA inspected Sunrise Orchards, Inc.'s juice processing facility from October 1-19, 2010, and found serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120) and Current Good Manufacturing Practices (CGMP) regulation (21 CFR Part 110). The firm's "100% Apple Cider" was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **HACCP Recordkeeping (21 CFR 120.12(a)):** Failure to maintain monitoring records for the Culling Critical Control Point (CCP), specifically regarding undamaged apples and patulin levels. The firm also failed to record checks for the metal screen's integrity at the "metal inclusion" CCP. 2. **CGMP Monitoring (21 CFR 120.6(b)):** Insufficient frequency in monitoring conditions and practices. This included: * **Food contact surfaces:** Post-pasteurization piping connected with duct tape and only water-flushed; juice batch tank lid holes closed with duct tape. * **Protection from adulteration:** Pasteurized juice leaking onto the bottle filling line; an opened juice bottle exposed to spray mist; torn bags of rice hulls exposed to the environment due to a