FDA Inspection
Ambu Sdn. Bhd.Ambu Sdn. Bhd. – FDA Inspection, Aug 17, 2023
Record Details
This FDA Inspection record concerns Ambu Sdn. Bhd., with an inspection on August 17, 2023, issued by the Office of Inspections and Investigations.
- Company
- Ambu Sdn. Bhd.
- Inspection Date
- August 17, 2023
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ID · 5783abe0-b089-4ecd-b8e7-e9384d609568
Inspection Facts
- Inspection number
- 1215014
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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Other FDA inspections of Ambu Sdn. Bhd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 15, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 19, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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