FDA WARNING_LETTER - A C Calderoni & Co. Inc. - December 20, 2017

On March 14, 2018, the FDA issued a Warning Letter to A.C. Calderoni & Co. following an inspection of their juice and drink mixer manufacturing facility in Brisbane, CA, on December 14, 18, and 20, 2017. The inspection revealed serious violations of the FDA's juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120), rendering their juice products adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act.

Key violations include: 1. **Failure to conduct a written hazard analysis (21 CFR 120.7(a)):** The firm did not identify food hazards, such as *Listeria monocytogenes* and metal fragments, for their Royal brand 100% lemon juice from concentrate. They also failed to perform the required 5-log reduction process (21 CFR 120.24(c)). 2. **Absence of a written HACCP plan (21 CFR 120.8(a)):** The firm lacked a HACCP plan to control identified hazards for their 100% Lemon Juice product. 3. **Inadequate monitoring of sanitation (21 CFR 120.6(b)):** The firm did not maintain sanitation records for all