FDA Inspection
Electronic Waveform Lab, Inc.Electronic Waveform Lab, Inc. – FDA Inspection, Feb 8, 2018
Record Details
This FDA Inspection record concerns Electronic Waveform Lab, Inc., with an inspection on February 8, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 0deee1bf-80a5-4b88-97f4-cde43fe53720
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1040264
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
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Other FDA inspections of Electronic Waveform Lab, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 11, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 6, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Electronic Waveform Lab, Inc.
- FDA Inspection 1196109 - 2023-01-11
- FDA Inspection 794748 - 2012-08-06
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