FDA WARNING_LETTER - Create-A-Pack Foods, Inc. - April 12, 2012

The FDA inspected Create-A-Pack Foods, Inc. from March 6 to April 12, 2012, finding violations across multiple product categories: thermally processed low-acid foods, acidified foods, dietary supplements, and 100% juice products.

Key violations include: - **Low-Acid Foods (21 CFR Parts 108, 113):** Failure to process according to scheduled processes (e.g., incorrect fill temperatures for chocolate and espresso products), inadequate documentation of thermal processing records, and failure to maintain initial distribution records for lot traceability. - **Acidified Foods (21 CFR Parts 108, 114):** Lack of process information for cap and headspace commercial sterility, inadequate container integrity testing (high cap failure rates for water products), failure to file scheduled processes for certain acidified products (e.g., prune juice, various flavors), and insufficient distribution traceability. - **Juice HACCP (21 CFR Part 120):** Failure to take corrective actions for critical limit deviations (e.g., cherry juice concentrate), inadequate monitoring of critical control points (e.g., cherry juice processing), and lack of validation for HACCP plans to ensure 5-log pathogen reduction for cherry juice and puree products. - **Unapproved New Drugs (Section 201(g)(1)(B), 505(a) of the Act):