FDA Inspection
AMBU LimitedAMBU Limited – FDA Inspection, Nov 7, 2013
Record Details
This FDA Inspection record concerns AMBU Limited, with an inspection on November 7, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- AMBU Limited
- Inspection Date
- November 7, 2013
- Product Type
- Devices
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ID · a3271114-d917-4866-89a6-0d32e85b940c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 857684
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of AMBU Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 16, 2026 | Not classified | Office of Inspections and Investigations | |
| October 25, 2018 | Not classified | Office of Inspections and Investigations | |
| May 20, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 2, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for AMBU Limited
- FDA Inspection 1314106 - 2026-04-16
- FDA Inspection 1071591 - 2018-10-25
- FDA Inspection 974130 - 2016-05-20
- FDA Inspection 733663 - 2011-06-02
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