FDA EIR - Vance Bioenergy Sdn. Bhd. - November 10, 2017

An FDA inspection of Vance Bioenergy Sdn. Bhd., a Malaysian manufacturer of food additives and cosmetic ingredients exported to the United States, was conducted on November 9-10, 2017. This initial inspection at the Pasir Gudang facility was performed under the regulatory framework of Modernized Current Good Manufacturing Practices (cGMP), specifically Compliance Program 7303.014 and Subparts A and F of 21 CFR 117, pertaining to preventive controls for human food.

Crucially, the inspection found no significant violations or issues; no FDA 483, Inspectional Observations, was issued. The facility demonstrated compliance, with no evidence of pest activity noted and training programs found to be in order. Therefore, no specific corrective actions were required.

However, during a closeout meeting, management was provided with and discussed guidance documents related to the Food Safety Modernization Act (FSMA). These included proposed rules on protecting food against intentional adulteration, sanitary transportation of human and animal food, and the final rule on preventive controls for human food. Electronic copies of 21 CFR 117 and the "Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry" were also supplied, emphasizing ongoing regulatory awareness and adherence.