# FDA 483 - MicroVention Costa Rica S.R.L. - May 23, 2022

Source: https://www.keypedia.com/records/483/microvention-costa-rica-srl/94d47834-c5d1-4003-9983-6aee6ce6f1fb

> FDA 483 for MicroVention Costa Rica S.R.L. on May 23, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MicroVention Costa Rica S.R.L.
- Inspection Date: 2022-05-23
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: MicroVention Inc. in Alajuela, Costa Rica, was inspected and cited for significant deficiencies in its quality system. Observations included inadequate process validation for catheter washing, insufficient software validation for lot tracking, and a failure to properly document quality testing results. Additionally, the firm did not adequately manage nonconformances or supplier corrective actions, indicating systemic issues in its quality control and CAPA processes.

## Related Documents

- [WARNING_LETTER - 2022-05-26](https://www.keypedia.com/records/warning_letter/microvention-costa-rica-srl/8398815e-8df3-4069-9bf9-3aef4ff88b9f)

## Related Officers

- [Sean T. Creighton](https://www.keypedia.com/people/sean-t-creighton/80ffecab-0a2d-4727-a11f-407b697f4503)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd