FDA Inspection
Deltex Medical LimitedDeltex Medical Limited – FDA Inspection, Mar 17, 2011
Record Details
This FDA Inspection record concerns Deltex Medical Limited, with an inspection on March 17, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Deltex Medical Limited
- Inspection Date
- March 17, 2011
- Product Type
- Devices
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ID · e7f264db-f60b-4e36-a0ec-ec87bd632f80
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 717853
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(f)Buildings
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.100(a)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 Deltex Medical Limited
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 1, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 23, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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