FDA WARNING_LETTER - Vibracare Gmbh - December 18, 2014

On April 17, 2015, the FDA issued a Warning Letter to Vibracare GmbH following an inspection from December 15-18, 2014, in Bremen, Germany. The inspection revealed that Vibracare's electric-powered percussive vests are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to document CAPA activities and results (21 CFR 820.100(a))**: The CAPA procedure lacks requirements for verification/validation of effectiveness and complete documentation. Vibracare's response to update procedures was deemed inadequate as it did not address retrospective evaluation of past CAPAs. 2. **Failure to establish and maintain design change procedures (21 CFR 820.30(i))**: The design change procedure does not require evaluation for necessary design control activities. A specific design change to a connector cable was implemented without prior review or approval. The adequacy of Vibracare's response to review past changes and update supplier agreements could not be determined. 3. **Failure to establish and maintain design review procedures (21 CFR 820.30(e))**: Formal documented design