FDA WARNING_LETTER - MicroVention Costa Rica S.R.L. - May 26, 2022

On September 30, 2022, the FDA issued a Warning Letter to Charlie Noel following an inspection from May 23-26, 2022, at their Alajuela, Costa Rica facility. The inspection revealed that the firm's medical devices, including Headway Microcatheter, LVIS, LVIS Jr, Scepter C and XC Occlusion Balloon Catheter, SOFIA Catheters, and BOBBY Balloon Guide Catheter, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to verify processes (21 CFR 820.75(a))**: The catheter wash limitation process validation lacked specified requirements, and justifications did not provide high assurance or approval. Biocompatibility testing (ISO 10993-1) was inadequate, missing pyrogenicity assessment, incorrect cytotoxicity acceptance criteria, and failure to address residual sterilant levels (ISO 10993-7). Software validation for the coating tracker lacked evidence of required repeat tests. The firm's CAPA (b)(4) was deemed inadequate. 2. **Inadequate CAPA procedures (21 CFR 820.100)**: The Supplier Corrective Action Request (SC