FDA WARNING_LETTER - Juicer Connections, Inc. - November 25, 2022

The FDA inspected The Juice Connection facility from October 24 to November 25, 2022, identifying serious violations of 21 CFR Part 120 (HACCP) and 21 CFR Part 117 (CGMP & PC rule). This resulted in an FDA Form 483 and a determination that food products are adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Label reviews also found misbranding violations for several products under 21 U.S.C. § 343.

The company's December 20, 2022, response, mentioning a consultant, employee HACCP retraining, and equipment purchases, was deemed insufficient due to a lack of supporting documentation for implementation and progress.

Key violations include: - **HACCP System (21 CFR 120):** Failure to fully implement monitoring, verification, and recordkeeping procedures, specifically for pH monitoring of low-acid juices, HPP treatment report review, and mesh inspection for metal detection. pH monitoring records were incomplete and showed incorrect values compared to FDA samples. The HACCP plan validation (21 CFR 120.11(b)) was inadequate, not assessing HPP efficacy throughout shelf life or covering all manufactured juice products. The single HACCP plan was not specific enough for each juice type.