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

Source: https://www.keypedia.com/records/warning_letter/microvention-costa-rica-srl/8398815e-8df3-4069-9bf9-3aef4ff88b9f

> FDA WARNING_LETTER for MicroVention Costa Rica S.R.L. on May 26, 2022. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: MicroVention Costa Rica S.R.L.
- Inspection Date: 2022-05-26
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Documents

- [483 - 2022-05-23](https://www.keypedia.com/records/483/microvention-costa-rica-srl/94d47834-c5d1-4003-9983-6aee6ce6f1fb)

## Related Officers

- [Amy Smith](https://www.keypedia.com/people/amy-smith/abbe6fab-ac37-4c07-913d-fce58d706312)
- [Bram D. Zuckerman](https://www.keypedia.com/people/bram-d-zuckerman/f1db0188-ca91-4c3a-828d-f3c6f7450e54)

Company: https://www.keypedia.com/companies/microvention-costa-rica-srl/6c6961b5-fea4-46c4-a62a-e443ccd105e9

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