FDA Inspection
G&B Electronic Design Ltd.G&B Electronic Design Ltd. – FDA Inspection, Apr 19, 2018
Record Details
This FDA Inspection record concerns G&B Electronic Design Ltd., with an inspection on April 19, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ef01685b-dc82-4d32-bbbe-cb7120c9b924
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1048799
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of G&B Electronic Design Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 2, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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