FDA Inspection
Medspira, LlcMedspira, Llc – FDA Inspection, Jun 27, 2025
Record Details
This FDA Inspection record concerns Medspira, Llc, with an inspection on June 27, 2025, issued by the Minneapolis District Office, covering medical devices & rad health.
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ID · 353a89bc-27c7-4bb7-a3c6-e35723a17718
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1275273
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
6- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
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Other FDA inspections of Medspira, Llc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 6, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 10, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medspira, Llc
- FDA Inspection 1227971 - 2024-01-16
- FDA Inspection 1064776 - 2018-09-06
- FDA Inspection 882714 - 2014-06-10
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