# FDA 483 - Medspira, Llc - January 16, 2024

Source: https://www.keypedia.com/records/483/medspira-llc/9c6a7d67-e9b9-49bb-ad42-3baadf5511f5

> FDA 483 for Medspira, Llc on January 16, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medspira, Llc
- Inspection Date: 2024-01-16
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Medspira, Llc received a Form 483 citing significant quality system deficiencies, primarily impacting the design and post-market surveillance of their Petite Catheter. The firm failed to adequately verify and validate design changes, maintain updated risk analyses despite numerous complaints, and establish effective procedures for corrective actions, nonconforming product control, and medical device reporting. These systemic issues led to the release of devices with known defects, including inflation/deflation problems and balloon ruptures, posing potential risks to patients.

## Related Documents

- [483 - 2025-06-27](https://www.keypedia.com/records/483/medspira-llc/cf864c61-8be0-440b-be57-2f5ce9585827)

## Related Officers

- [Mildred J. Tures](https://www.keypedia.com/people/mildred-j-tures/c21df23d-580f-4cdc-94a1-194d981e41be)

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

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