Rebuilder Medical, Inc. – FDA Warning Letter, Jan 11, 2011

On March 8, 2011, the FDA issued a Warning Letter to ReBuilder Medical, Inc. following a January 4 and 11, 2011 inspection. The inspection revealed that the firm's ReBuilder™ Transcutaneous Nerve Stimulator and ReBuilder™ Bucket Transcutaneous Nerve Stimulator devices are adulterated under section 501(h) of the Act, as their manufacturing, packing, storage, or installation methods, facilities, or controls do not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 C.F.R. Part 820).

The FDA found multiple violations, including: 1. **Failure to maintain non-conforming product procedures (21 C.F.R. 820.90(a)):** Complaint logs lacked documentation of receipt dates, investigations, conclusions, and disposition dates for returned devices. The firm's response was inadequate, failing to explain compliance assurance or employee training plans for revised procedures. 2. **Failure to establish rework procedures (21 CFR 820.90(b)(2)):** No procedures or adequate records for rework of non-conforming signal generator components were maintained. 11.6% of signal generator components required rework between 10/25/2010 and 11/30/2010.