FDA 483 - bioMerieux, Inc. - June 14, 2013

bioMerieux, Inc. in Durham, NC, a medical device manufacturer of blood culture bottles, was cited for significant deficiencies across its quality system. The inspection revealed inadequate production process controls, failures in handling nonconforming products, and widespread issues with process validation and corrective and preventive actions. Additionally, the firm demonstrated shortcomings in design control documentation, complaint investigations, and personnel training.