# FDA 483 - Boule Medical AB - May 11, 2018

Source: https://www.keypedia.com/records/483/boule-medical-ab/337c4dfd-f1c7-4770-844a-75e4d566c4ca

> FDA 483 for Boule Medical AB on May 11, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boule Medical AB
- Inspection Date: 2018-05-11
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Boule Medical AB, a medical device manufacturer in Spanga, Sweden, was cited for multiple quality system deficiencies during an FDA inspection from May 7-11, 2018. The firm lacked adequate procedures for corrective and preventive actions, complaint handling, supplier evaluation, device history records, and process controls. Additionally, written Medical Device Reporting (MDR) procedures were not developed, indicating systemic issues in their manufacturing and post-market surveillance processes for products like the Medonic M-series Hematology Analyzers.

## Related Officers

- [Thai T. Duong](https://www.keypedia.com/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

Company: https://www.keypedia.com/companies/boule-medical-ab/39288ca9-46b0-407c-9e54-70a7145ae878

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