FDA Inspection
DoubleDay Acquisitions dba CSAFE GlobalDoubleDay Acquisitions dba CSAFE Global – FDA Inspection, Aug 4, 2015
Record Details
This FDA Inspection record concerns DoubleDay Acquisitions dba CSAFE Global, with an inspection on August 4, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 4, 2015
- Product Type
- Devices
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ID · ec3a1c0a-34ab-4b55-b730-0e64dfbb8435
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 938778
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design validation - production units
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Other FDA inspections of DoubleDay Acquisitions dba CSAFE Global
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 25, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 10, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for DoubleDay Acquisitions dba CSAFE Global
- FDA Inspection 1215859 - 2023-07-25
- FDA Inspection 1074006 - 2018-12-10
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