# FDA 483 - B-K Medical A/S - January 26, 2017

Source: https://www.keypedia.com/records/483/b-k-medical-as/52413218-6b41-41ec-848d-c05b9f31563a

> FDA 483 for B-K Medical A/S on January 26, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: B-K Medical A/S
- Inspection Date: 2017-01-26
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: B-K Medical A/S, a medical device manufacturer in Herlev, Denmark, was inspected by the FDA from January 23-26, 2017. The inspection revealed significant deficiencies in the firm's complaint handling, medical device reporting (MDR) procedures, and personnel training documentation. These issues indicate a lack of adequate controls for managing product quality and safety concerns.

## Related Officers

- [Investigator](https://www.keypedia.com/people/janet-pulver/d46b01cd-8c3d-4a54-bb91-843e0f94de89)

Company: https://www.keypedia.com/companies/b-k-medical-as/a2db60d6-c656-444d-bbb3-27d6134bbd7b

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