FDA WARNING_LETTER - Probed Medical Technologies, Inc. - September 15, 2011

On September 12-15, 2011, an FDA inspection of Probed Medical Technologies, Inc. in Abbotsford, Canada, revealed that their device, the Freedom Bed, was adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation 21 CFR Part 820.

The inspection identified four key violations: 1. **Failure to establish and maintain adequate procedures for design changes (21 CFR 820.30(i)):** The firm failed to document validation/verification of design changes, such as a bolt size change for a "clunk" noise and a design change in October 2008, to ensure effectiveness and no adverse effects on the finished product. The firm's response was inadequate as it lacked a modified procedure and retrospective review documentation. 2. **Failure to establish and maintain adequate procedures for finished device acceptance (21 CFR 820.80(d)):** Written procedures for finished product testing, specifically MP018, did not cover hand control, side rail, and battery charger testing. The firm's response was inadequate, lacking evidence of revised procedures, training, or comprehensive testing documentation. 3. **Failure to establish and maintain adequate requirements for suppliers (21 CFR 820.50(a)(2)):