FDA WARNING_LETTER - Healthy Choice Island Blends, Inc. - September 28, 2010

The FDA inspected Healthy Choice Island Blends, Inc. from September 13-28, 2010, revealing serious deviations from juice Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 120) and Current Good Manufacturing Practice (21 CFR Part 110). Consequently, the firm's juice products are deemed adulterated under Section 402(a)(4) of the Food Drug and Cosmetic Act. Significant violations include the HACCP plan not being specific to each juice type (21 CFR 120.8(a)(2)), and new HACCP plans for low-acid juices lacking adequate control measures for Clostridium botulinum (21 CFR 120.24(a)). The firm failed to implement its HACCP recordkeeping system, specifically for pasteurization critical control point monitoring, with incomplete or missing data (21 CFR 120.8(a), (b)(7), 120.12(b)(4)). Additionally, sanitation conditions and practices were inadequately monitored, failing to comply with GMP requirements (21 CFR 120.6(b), 21 CFR Part 110), evidenced by issues like cross-contamination, poor handwashing facilities, adulteration protection, toxic compound management, and pest exclusion. The firm also failed to maintain adequate sanitation control records (21 CFR 120.6(c), 120.12(b)(2), 120.12(b)(3)). Previous responses to the FDA-483 were deemed inadequate due to a lack of supporting documentation. The FDA requires prompt written notification within 15 working days detailing corrective actions, including documentation like process authority engagement or scheduled process filings. Failure to implement lasting corrections may lead to regulatory actions, such as product seizure or injunctions against the firm's operations.