# FDA 483 - Medspira, Llc - June 27, 2025

Source: https://www.globalkeysolutions.net/records/483/medspira-llc/cf864c61-8be0-440b-be57-2f5ce9585827

> FDA 483 for Medspira, Llc on June 27, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medspira, Llc
- Inspection Date: 2025-06-27
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Medspira, LLC, a medical device manufacturer in Minneapolis, MN, was inspected by the FDA and received a Form 483 with six observations, many of which were repeat findings. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning corrective and preventive actions, non-conforming product control, complaint handling, design change, design risk analysis documentation, and document control. These issues indicate a systemic failure to adequately establish and implement critical procedures for ensuring product quality and safety.

## Related Documents

- [483 - 2024-01-16](https://www.globalkeysolutions.net/records/483/medspira-llc/9c6a7d67-e9b9-49bb-ad42-3baadf5511f5)

## Related Officers

- [Chad E. Schmear](https://www.globalkeysolutions.net/people/chad-e-schmear/275a4c57-d288-46f9-8257-64fcd96159ce)

Company: https://www.globalkeysolutions.net/companies/medspira-llc/7eb8121c-40f0-41dd-8fa0-c261997ae620

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