# FDA 483 - rms Company - September 12, 2025

Source: https://www.keypedia.com/records/483/rms-company/cea993fb-b57b-4c28-93f0-6942e6283c6e

> FDA 483 for rms Company on September 12, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: rms Company
- Inspection Date: 2025-09-12
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: rma Company in Minneapolis, MN was inspected from 9/10/2025 to 9/12/2025 and received a Form FDA 483 with two observations. The inspection revealed deficiencies in establishing adequate procedures for environmental control, including insufficient documentation of investigations for cleanroom and endotoxin monitoring excursions, and improper recording of cleanroom pressure. Additionally, the firm's corrective and preventive actions were found to be inadequate to prevent recurrence of cleanroom monitoring issues.

## Related Documents

- [483 - 2022-05-18](https://www.keypedia.com/records/483/rms-company/dc0c144b-e47f-499c-9bae-88099fa48188)

## Related Officers

- [Albert L. Nguyen](https://www.keypedia.com/people/albert-l-nguyen/496338d0-71c4-43da-92f0-09515559d9fc)

Company: https://www.keypedia.com/companies/rms-company/35265af4-630a-4117-a899-d1497aa0adc0

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