FDA WARNING_LETTER - Back To Back Medical, LLC - November 07, 2013

On January 13, 2014, the FDA issued a Warning Letter to Back To Back Medical, LLC, following a November 6-7, 2013 inspection. The firm imports, remanufactures, and repairs reusable pulse oximetry (SpO2) probes and sensors, which are classified as devices. The FDA considers the firm a manufacturer due to significant component changes (cables, photo detectors, LEDs) during remanufacturing, potentially affecting performance/safety and not covered by original OEM premarket notifications.

The inspection revealed the devices are adulterated under 21 U.S.C. § 351(h) because manufacturing methods, facilities, or controls do not conform to Quality System (QS) regulation (21 CFR Part 820) Current Good Manufacturing Practice (CGMP) requirements. The firm's November 21, 2013, response to the FDA 483 was deemed inadequate for failing to outline specific steps for compliance.

Violations include: 1. Failure to establish and maintain design control procedures (21 CFR 820.30(a)), including documenting whether remanufacturing changes require 510(k) submissions. 2. Failure to establish CAPA procedures (21 CFR 820.100(a)), including analysis of quality data, investigation of nonconformities,