FDA Inspection
ErgoMed, Inc.ErgoMed, Inc. – FDA Inspection, Dec 6, 2023
Record Details
This FDA Inspection record concerns ErgoMed, Inc., with an inspection on December 6, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b21211a2-1a97-450e-b863-f952b5cf6814
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1224604
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.198(a)Complaints
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 820.198(a)Complaints
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
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Other FDA inspections of ErgoMed, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 5, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 5, 2021 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 23, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for ErgoMed, Inc.
- FDA Inspection 1181395 - 2022-10-05
- FDA Inspection 1156173 - 2021-11-05
- FDA Inspection 1101119 - 2019-08-23
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