Virginia-based device manufacturer S. Jackson received a Form 483 for repeat corrective and preventive action (CAPA) and risk analysis deficiencies following a December inspection by the FDA of its Alexandria facility.

BioVision Technologies, a Boulder, Colo.-based device company, has shut down in the wake of an FDA inspection that observed multiple failures in procedures, controls and documentation.

Inadequate procedures for validations, design changes and complaints were spelled out in a five-observation Form 483 handed to Pemco, a cardiothoracic surgical devicemaker, after an inspection of its facility in Independence, Ohio last December.