BioMedix Vascular Solutions failed to follow current Good Manufacturing Practices at its St. Paul, MN, facility that manufactures the PADnet+ noninvasive cardiovascular blood flow monitoring system, according to an FDA warning letter.
The warning letter says BioMedix failed to:
- Ensure a quality system was fully implemented and maintained at all levels of the organization
- Investigate complaints about possible device failure
- Implement procedures for corrective and preventive actions
- Conduct quality audits at regular intervals
BioMedix also allegedly referred to the PADnet+ as FDA approved in brochures, even though the FDA has not approved the device.