FDA Inspection
Etymonic Design IncEtymonic Design Inc – FDA Inspection, Feb 9, 2023
Record Details
This FDA Inspection record concerns Etymonic Design Inc, with an inspection on February 9, 2023, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Etymonic Design Inc
- Inspection Date
- February 9, 2023
- Product Type
- Devices
View Company Profile
ID · c3da4024-1b0b-4b77-aa6e-34242c462b39
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1196889
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.30(d)Design output - review and approval
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.30(d)Design output - review and approval
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
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Other FDA inspections of Etymonic Design Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 23, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 23, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Etymonic Design Inc
- FDA Inspection 1119023 - 2020-01-23
- FDA Inspection 800016 - 2012-08-23
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