FDA Inspection
CPE1 LLCCPE1 LLC – FDA Inspection, Mar 15, 2019
Record Details
This FDA Inspection record concerns CPE1 LLC, with an inspection on March 15, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e8ac4526-7a2a-4340-8007-221107813bf4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1083531
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
Other FDA inspections of CPE1 LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2025 | Not classified | Florida District Office | |
| November 21, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 13, 2019 | Not classified | Florida District Office |
Other documents for CPE1 LLC
- FDA Inspection 1283584 - 2025-09-04
- FDA Inspection 1191024 - 2022-11-21
- FDA Inspection 1083540 - 2019-03-13
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