FDA WARNING_LETTER - O Guest Ranch Maui LLC/dba Surfing Goat Dairy - August 26, 2012

On August 23-26, 2012, the FDA inspected Thomas E. Kafsack's seafood processing facility at 3651 Omaopio Road, Kula, HI. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation for foods (21 CFR Part 110).

Specifically, the firm failed to conduct a hazard analysis and implement a written HACCP plan for "Alaska Delight Goat Cheese," "It's Not Sushi Cream Cheese," and "Pirate's Desire Cream Cheese." This omission leaves uncontrolled food safety hazards such as pathogenic bacteria growth, allergens, and metal and glass inclusions.

These violations render the aforementioned products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions. The FDA warned that failure to promptly correct these violations could lead to further action, including product seizure and injunction against the firm's operation.

The firm was required to respond in writing within fifteen working days, outlining specific corrective actions, including HACCP and verification records. The letter also stated that this list of violations might not be exhaustive and emphasized the firm's responsibility for overall compliance with all applicable regulations.