# FDA WARNING_LETTER - ARB Medical, LLC - August 11, 2015

Source: https://www.keypedia.com/records/warning_letter/arb-medical-llc/4300f499-a07b-4003-bcce-12375ce0dc00

> FDA WARNING_LETTER for ARB Medical, LLC on August 11, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: ARB Medical, LLC
- Inspection Date: 2015-08-11
- Product Type: Devices
- Office Name: Minneapolis District Office
- Summary: On December 22, 2015, the FDA issued a Warning Letter to ARB Medical, LLC, following an inspection from August 5-11, 2015, at their Minnetonka, Minnesota facility. The inspection revealed that their polymeric surgical meshes, classified as devices, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include:
1.  **Process Validation (21 CFR 820.75(a)):** Failure to adequately validate the (b)(4) operation for (b)(4), with the supplier's study not varying process parameters.
2.  **Design Output (21 CFR 820.30(d)):** Critical product characteristics (e.g., mesh thickness, tensile strength, pore size) for polypropylene and PTFE surgical meshes (Rebound HRD and HRD-V) were not reviewed and approved before release or tested prior to shipment.
3.  **Design Validation (21 CFR 820.30(g)):** Failure to ensure devices conformed to user needs and intended uses, lacking testing for critical surgical mesh characteristics.
4.  **Incoming Product Acceptance (21 CFR 820.80(b)):** Supplier agreement

## Related Officers

- [Acting Assistant Commissioner](https://www.keypedia.com/people/michael-dutcher/5e9981f8-673f-4a2c-a0b5-dd5e8e8de1f4)
- [David E. Bakken](https://www.keypedia.com/people/david-e-bakken/d94d5ec7-4390-401a-b057-4c531b7a5558)

Company: https://www.keypedia.com/companies/arb-medical-llc/b5f819dd-0f85-4834-8045-8d44f6440bc2

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d