FDA Inspection
HertART ApSHertART ApS – FDA Inspection, Mar 21, 2018
Record Details
This FDA Inspection record concerns HertART ApS, with an inspection on March 21, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9e1c533f-5d1f-4633-b7cc-99be7af74fc8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1047589
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.250(a)Statistical techniques - 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 820.75(a)Documentation
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of HertART ApS
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 28, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 29, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for HertART ApS
- FDA Inspection 1220574 - 2023-08-28
- FDA Inspection 927679 - 2015-04-29
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