# FDA WARNING_LETTER - Vibracare Gmbh - December 18, 2014

Source: https://www.keypedia.com/records/warning_letter/vibracare-gmbh/420cc478-2e3d-40ef-813e-9e03597195b6

> FDA WARNING_LETTER for Vibracare Gmbh on December 18, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Vibracare Gmbh
- Inspection Date: 2014-12-18
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [Jan B. Welch](https://www.keypedia.com/people/jan-b-welch/65bfaf7c-7ce6-4c33-80bd-090efbf2eec5)

Company: https://www.keypedia.com/companies/vibracare-gmbh/f57451ab-746e-459c-ad02-a9e678e19fc4

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7