Company
United StatesElectronic Waveform Lab, Inc., Huntington Beach, CA – FDA Inspections
Inspection records and compliance data for Electronic Waveform Lab, Inc. in Huntington Beach, California. 3 FDA inspections on record, 1 Form 483, last inspected January 11, 2023.
Company Profile
This profile covers Electronic Waveform Lab, Inc. based in Huntington Beach, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected August 6, 2012. Last inspected January 11, 2023.
Most cited issue areas
- Lack of or inadequate DHR procedures1 inspection
- Lack of or inadequate final acceptance procedures1 inspection
- Lack of or inadequate procedures for labeling1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 11, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1196109 |
| February 8, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1040264 |
| August 6, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 794748 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Electronic Waveform Lab, Inc.
FEI Number
2023152
Address
5702 Bolsa Ave, Huntington Beach, California 92649, United States
Country
United States
ID: b497cd0e-ddf2-44b8-ad08-657d88430bc7