# FDA 483 - rms Surgical - April 01, 2022

Source: https://www.globalkeysolutions.net/records/483/rms-surgical/8ad15214-b157-407a-a5f2-885cd8097532

> FDA 483 for rms Surgical on April 01, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: rms Surgical
- Inspection Date: 2022-04-01
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: rms Surgical in Anoka, MN, was inspected from March 29 to April 1, 2022, and received a Form FDA 483 with two observations. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) system, including actions taken outside the formal system and a lack of verification of effectiveness. Additionally, the firm's document control procedures were found to be inadequately established and maintained.

## Related Officers

- [Jamie P. Webb](https://www.globalkeysolutions.net/people/jamie-p-webb/9e052469-54f7-4d56-b977-27babbdac09b)
- [investigator](https://www.globalkeysolutions.net/people/jennifer-s-ness/532f8a81-e393-4e83-b5f2-a72362e966de)

Company: https://www.globalkeysolutions.net/companies/rms-surgical/835cbabe-e273-44d8-9353-61c8b2b26a68

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