ARB Medical, LLC – FDA Warning Letter, Aug 11, 2015

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