FDA Inspection
ErgoMed, Inc.ErgoMed, Inc. – FDA Inspection, Nov 5, 2021
Record Details
This FDA Inspection record concerns ErgoMed, Inc., with an inspection on November 5, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ErgoMed, Inc.
- Inspection Date
- November 5, 2021
- Product Type
- Devices
View Company Profile
ID · c89f3ae6-3dc4-42b4-a4b8-4a9ceb10845c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1156173
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ErgoMed, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 6, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 5, 2022 | 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 1224604 - 2023-12-06
- FDA Inspection 1181395 - 2022-10-05
- FDA Inspection 1101119 - 2019-08-23
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