# FDA 483 - Annex Medical, Inc. - June 09, 2023

Source: https://www.keypedia.com/records/483/annex-medical-inc/5db4250c-ecab-4f5c-8450-41fe7f4667f7

> FDA 483 for Annex Medical, Inc. on June 09, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Annex Medical, Inc.
- Inspection Date: 2023-06-09
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Annex Medical, Inc., a medical device manufacturer, received a Form 483 with three observations highlighting significant deficiencies in their quality system. The inspection revealed inadequate implementation of corrective and preventive action procedures, insufficient controls to prevent product contamination, and poorly defined acceptance activity procedures. These issues indicate a need for improved documentation, justification, and established criteria across several critical processes.

## Related Officers

- [Ulysses D. Singleton](https://www.keypedia.com/people/ulysses-d-singleton/e62f9da3-2c82-4ad7-910d-2da18144c789)
- [Investigator ](https://www.keypedia.com/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.keypedia.com/companies/annex-medical-inc/fdb267aa-ba89-483e-a3c4-d3673014fea4

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d