Life Sciences

BioMedix receives FDA warning letter

Device Regulation Alert: Safety, Compliance and Reimbursement News, January 3, 2008

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.

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