FDA Inspection
IntelleWave, Inc.IntelleWave, Inc. – FDA Inspection, Aug 2, 2017
Record Details
This FDA Inspection record concerns IntelleWave, Inc., with an inspection on August 2, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6a9174c4-313a-4749-9d9d-9e2103700391
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1020784
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Complaints
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of IntelleWave, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 25, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for IntelleWave, Inc.
- FDA Inspection 1237790 - 2024-04-25
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