FDA Inspection
Avant Wellness Systems, Inc.Avant Wellness Systems, Inc. – FDA Inspection, Nov 8, 2017
Record Details
This FDA Inspection record concerns Avant Wellness Systems, Inc., with an inspection on November 8, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · f46469b7-90c8-4636-8c80-db90ae26977e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031068
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.80(e)Documentation
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Avant Wellness Systems, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2024 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| July 21, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Avant Wellness Systems, Inc.
- FDA Inspection 1232042 - 2024-02-01
- FDA Inspection 1147628 - 2021-07-21
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.