FDA EIR - Lonza Greenwood LLC - June 24, 2019

An FDA comprehensive surveillance inspection was conducted at Capsugel Manufacturing Inc., owned by Lonza, located in Greenwood, SC, from April 23 to April 24, 2019. This inspection focused on the firm's operations as a manufacturer of hard-shell capsules used as components for dietary supplements. The regulatory framework for the inspection included CFR 117 (Parts A, B, and F) and CPG 7321.008, which pertains to Dietary Supplements – Domestic and Import. The inspection involved a thorough review of the firm's distribution operations, employee practices and training, records, complaint handling, recalls, sanitation procedures, pest control measures, and ingredient management. A tour of the facility and observations of manufacturing processes were also conducted. Significantly, the inspection concluded with no objectionable conditions identified. Consequently, an FDA-483, Inspectional Observations Form, was not issued to the firm's management. This indicates that Capsugel Manufacturing Inc. was found to be in compliance with the relevant FDA regulations during this inspection period. At the closeout meeting, management acknowledged their ongoing responsibility to ensure full compliance with all FDA regulations, and the agency's available legal sanctions were briefly discussed. No specific actions were required from the company following this inspection.