Lebanese Arak Corp – FDA Warning Letter, Apr 29, 2011

On September 22, 2011, the FDA issued a Warning Letter to Lebanese Arak Corp following an inspection from April 25-29, 2011, which revealed serious violations of juice Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 120) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110).

The FDA found Lebanese Arak Corp's lemon and lime juice products adulterated due to insanitary conditions. Key violations included: 1. **Inadequate HACCP Plan for Pathogen Control:** The critical limit of "pH less than 4.6" for lemon and lime juices at the blending CCP was deemed insufficient to ensure a 5-log reduction of pertinent microorganisms, including *Listeria monocytogenes*. A validation study provided was found inadequate as it used a pharmaceutical effectiveness test (USP 24 <51>) not intended for 5-log reduction validation and lacked critical test parameters. 2. **Missing CCP for Sulfites:** The HACCP plan for 100% lemon and lime juices lacked a critical control point at the labeling step to control the hazard of added sulfites, despite the firm identifying sulfites as a significant hazard. 3. **Sanitation Deficiencies:** The firm failed to adequately monitor sanitation conditions and practices. Observed issues included: * **Food Contact Surfaces:** Water supply