FDA WARNING_LETTER - Sally's Cider Press - October 16, 2012

On December 20, 2012, the FDA issued a Warning Letter to Sally's Cider Press following an inspection from September 27 to October 16, 2012. The inspection revealed serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120) and Current Good Manufacturing Practice (21 CFR Part 110).

The firm's UV-light treated, refrigerated apple cider was deemed adulterated due to insanitary conditions. Key violations included: * **Inadequate HACCP Plan:** The plan failed to list food safety hazards like *Escherichia coli O157:H7* and *Cryptosporidium parvum*, and did not include the UV light treatment as a critical control point (CCP) to achieve a 5-log reduction for these hazards. * **Lack of Records:** No records were maintained to document the monitoring of CCPs for the identified hazards. * **Failure to Validate HACCP Plan:** The HACCP plan was not validated after the process change to include "Cider Sure" UV light treatment. * **Sanitation Deficiencies:** The firm failed to adequately monitor sanitation conditions. Specifically, hot water was unavailable in the restroom for handwashing, and non-food grade hoses (Goodyear heater hoses) were used to transfer UV-treated apple juice.

Sally's Cider Press was