# FDA 483 - NanoString, A Bruker Company - August 09, 2024

Source: https://www.keypedia.com/records/483/nanostring-a-bruker-company/caafc536-63a9-4241-b794-735e9947e4bd

> FDA 483 for NanoString, A Bruker Company on August 09, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: NanoString, A Bruker Company
- Inspection Date: 2024-08-09
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of NanoString, A Bruker Company, in Seattle, WA, revealed significant deficiencies in the firm's complaint handling procedures. The company failed to adequately maintain complaint files and did not comply with its own standard operating procedures for complaint handling in multiple instances. This included insufficient documentation regarding corrective and preventive actions (CAPA) and assessments for Medical Device Reporting (MDR) requirements.

## Related Officers

- [Brian R. Hendricks](https://www.keypedia.com/people/brian-r-hendricks/c2759597-935c-4b48-8fc8-2d1443098cc1)

Company: https://www.keypedia.com/companies/nanostring-a-bruker-company/264b102c-1a14-4913-bcac-c28d02ffee7f

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822