FDA WARNING_LETTER - Sunnyside Orchard - October 12, 2018

The FDA issued a Warning Letter to Sunnyside Orchard following an inspection of their apple cider processing facility from September 27 to October 12, 2018. The inspection revealed serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 120, rendering their apple cider adulterated. The firm had not responded to the initial FDA-483.

Key violations include the failure to take appropriate corrective actions when critical limit deviations occurred, specifically raw cider flowing through a powered-off UV unit. The firm's HACCP plan's corrective actions for the UV 5-log reduction Critical Control Point were deemed inappropriate, as they did not address the cause of deviations or prevent under-processed cider from entering commerce. Sunnyside Orchard also failed to implement monitoring procedures outlined in their HACCP plan, such as culling for Patulin and screen checks for metal inclusion, and showed discrepancies in UV unit monitoring records. Furthermore, the firm did not adequately monitor conditions and practices to ensure current good manufacturing practice (cGMP) conformance, evidenced by the lack of routine sanitizer use, observed debris on food contact surfaces after sanitation, and significant pest activity (rodents and fruit flies) in processing areas. Finally, the firm failed to maintain required sanitation control records.

The FDA requires prompt corrective action, with a written response due within 15 business days detailing specific steps, prevention plans, and a timetable for completion. Failure to comply may lead to legal action, including seizure and injunction, and the assessment of reinspection fees.