l. neil jones food company – FDA Warning Letter, Jan 16, 2008

On January 10, 11, and 16, 2008, the FDA inspected Mr. Jones' juice processing facility at 1701 West 16th Street, Vancouver, Washington, and found serious violations of juice Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 120) and Good Manufacturing Practice (GMP) regulations (21 CFR Part 110). The primary violation was the firm's HACCP plan for apple juice concentrate failing to list patulin as a reasonably likely food hazard, despite records showing patulin levels exceeding 50 parts per billion (ppb) in finished product lots, which may render the product injurious to health.

The FDA stated that the presence of patulin at these levels indicates it is a reasonably likely hazard that must be addressed in the HACCP plan. The firm's practice of blending high-patulin lots with acceptable lots was deemed an unacceptable means of addressing the hazard and could result in adulterated blended product, referencing FDA's Compliance Policy Guide, Section 555.200.

Consequently, the apple juice concentrate products are considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)). The FDA warned that failure to promptly correct these violations could lead to further action,