FDA Inspection
Ambu Sdn. Bhd.Ambu Sdn. Bhd. – FDA Inspection, Sep 19, 2013
Record Details
This FDA Inspection record concerns Ambu Sdn. Bhd., with an inspection on September 19, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ambu Sdn. Bhd.
- Inspection Date
- September 19, 2013
- Product Type
- Devices
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ID · ea438711-5413-4fc3-bd57-95c4100a2698
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 853156
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Ambu Sdn. Bhd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 17, 2023 | Not classified | Office of Inspections and Investigations | |
| April 15, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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