FDA Inspection
Electron Beam Sdn. Bhd.Electron Beam Sdn. Bhd. – FDA Inspection, Jan 12, 2023
Record Details
This FDA Inspection record concerns Electron Beam Sdn. Bhd., with an inspection on January 12, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bb8e5527-891c-41fc-a099-66f8726085a0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195667
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Electron Beam Sdn. Bhd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 10, 2022 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Electron Beam Sdn. Bhd.
- FDA Inspection 1173732 - 2022-05-10
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