FDA 483 - bioMerieux, Inc. - January 05, 2016

An FDA inspection of bioMerieux, Inc. in Durham, NC, a manufacturer of culture media products, revealed numerous deficiencies across its quality management system. Observations included inadequate complaint evaluations, unreported field corrective actions, unsupported raw material expiration dating, and significant issues with environmental monitoring, equipment maintenance, and calibration. Furthermore, the firm demonstrated systemic failures in personnel training, documentation control, product handling reconciliation, and quality audit procedures.