# FDA 483 - Occlutech International AB - May 05, 2022

Source: https://www.keypedia.com/records/483/occlutech-international-ab/7e4757c1-10ff-4e4f-91f3-9ef73a7acd25

> FDA 483 for Occlutech International AB on May 05, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Occlutech International AB
- Inspection Date: 2022-05-05
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Occlutech International AB, a medical device manufacturer in Helsingborg, Sweden, was cited for four observations during an FDA inspection. The firm failed to establish adequate procedures for process controls, complaint handling, incoming product acceptance, and device history records. These deficiencies indicate a need for improved quality system documentation and adherence to regulatory requirements.

## Related Officers

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

Company: https://www.keypedia.com/companies/occlutech-international-ab/5db91838-b182-4f56-ae3d-3c205a1523fe

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