FDA Inspection
Diasol, IncDiasol, Inc – FDA Inspection, Feb 3, 2010
Record Details
This FDA Inspection record concerns Diasol, Inc, with an inspection on February 3, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Diasol, Inc
- Inspection Date
- February 3, 2010
- Product Type
- Devices
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ID · 9d25bf9c-bd37-419b-9b12-76a2b7879a6e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 643583
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.72(b)(2)Calibration documentation
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Other FDA inspections of Diasol, Inc
12| Date | Classification | Office | Project area |
|---|---|---|---|
| August 19, 2025 | OAI | Denver District Office | Compliance: Medical Devices |
| February 28, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 28, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 28, 2018 | Not classified | Denver District Office | Postmarket Assurance: Devices |
| June 21, 2017 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Diasol, Inc
- FDA Inspection 1280179 - 2025-08-19
- FDA Inspection 1231444 - 2024-02-28
- FDA Inspection 1145524 - 2021-06-28
- FDA Inspection 1067155 - 2018-09-28
- FDA Inspection 1015055 - 2017-06-21
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