FDA EIR - Medolac Laboratories, A Public Benefit Corporation - November 15, 2018

An FDA inspection of Medolac Laboratories, A Public Benefit Corporation, occurred from November 13-15, 2018, in Boulder City, NV. This comprehensive establishment inspection was initiated as a follow-up to a Salmonella Agbeni outbreak affecting premature infants, potentially associated with human breast milk products. The regulatory scope included the Domestic Low Acid Canned Food (LACF) and Acidified Food Program (CPGM 7303.803A), the NLEA and General Labeling Program (CPGM 7321.005), and a GMP/Limited Scope Preventive Controls (PC) inspection. Investigators reviewed raw material receiving, production, sanitation, employee practices, finished product packaging, labeling, and critical records related to thermal processing and consumer complaints. While the firm was not manufacturing during the inspection due to a temporary building code issue at its newly relocated facility, the thorough walk-through and records review found no objectionable conditions. Consequently, no Form FDA 483, Inspectional Observations, was issued. Seven finished product samples were collected for analysis for Salmonella Agbeni. All inspection findings and collected information will be forwarded to the Coordinated Outbreak Response and Evaluation (CORE) team.