FDA Inspection
Augustine Temperature Management, LLCAugustine Temperature Management, LLC – FDA Inspection, Sep 25, 2026
Record Details
This FDA Inspection record concerns Augustine Temperature Management, LLC, with an inspection on September 25, 2026, issued by the Minneapolis District Office, covering medical devices & rad health.
- Inspection Date
- September 25, 2026
- Product Type
- Medical Devices & Rad Health
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ID · ea6d7200-30a8-4e42-beac-3b1ed942be87
Inspection Facts
- Inspection number
- 1337488
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- ISO 13485:2016 Clause 7.3.7Design and development validation not performed as planned
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Other FDA inspections of Augustine Temperature Management, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 27, 2024 | OAI | Minneapolis District Office | Compliance: Medical Devices |
| September 19, 2023 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 4, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 26, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 14, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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