FDA WARNING_LETTER - Glen Willow Orchards - October 24, 2007

On October 22-24, 2007, the FDA inspected Glen Willow Orchards' juice processing facility in Avondale, Pennsylvania, and found serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 120, promulgated under Section 361 of the Public Health Service Act (PHS Act).

The significant violation identified was the firm's failure to have and implement a written HACCP plan for its apple cider to control the food safety hazard of pathogens, as required by 21 CFR 120.8(a). The letter clarifies that Glen Willow Orchards is subject to this regulation because it sells juice wholesale and therefore does not qualify as a retail establishment under 21 CFR 120.3(1).

The FDA warned that failure to promptly correct these violations could result in further action, including injunctions to prevent the firm from operating. Glen Willow Orchards was required to respond in writing within fifteen working days of receiving the letter, outlining specific corrective actions, including documentation such as HACCP and verification records. If all corrections could not be completed, the firm needed to explain the delay and provide a timeline for completion. The letter also stated that it might not list all violations and that the firm is responsible for ensuring full compliance with the PHS Act and 21 CFR Part 120.