Apple Valley Orchards, LLC. – FDA Warning Letter, Oct 30, 2013

The FDA inspected Apple Valley Orchards' pasteurized apple cider facility on October 28 and 30, 2013, revealing serious violations of the Juice Hazard Analysis Critical Control Point (HACCP) regulation (21 CFR Part 120) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110). These deficiencies render the firm's juice products adulterated under Section 402(a)(4) of the Food Drug and Cosmetic Act. Key violations include the failure to maintain HACCP records for critical control point monitoring (21 CFR 120.12(a)(4)(i)) and sanitation monitoring records for water safety (21 CFR 120.6(c)). The firm also failed to adequately monitor the protection of food and food contact surfaces from adulteration, citing issues like unmonitored metal grinders, rusted equipment, unshielded lights, and an opening to the outside (21 CFR 120.6(b)). Furthermore, the HACCP plan had not been validated annually since May 2012 (21 CFR 120.11(b)). CGMP violations included employees not wearing appropriate hair restraints (21 CFR 110.10(b)(6)) and insufficient space for equipment and material storage, with items stored against walls (21 CFR 110.20(b)(1) and (b)(4)). The FDA requires a written response within 15 working days detailing specific corrective actions and supporting documentation. Failure to promptly correct these violations may result in product seizure or an injunction against the firm's operations.