FDA Inspection
DoubleDay Acquisitions dba CSAFE GlobalDoubleDay Acquisitions dba CSAFE Global – FDA Inspection, Dec 10, 2018
Record Details
This FDA Inspection record concerns DoubleDay Acquisitions dba CSAFE Global, with an inspection on December 10, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Teresa K. Kastner
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ID · bcbca942-a76d-476a-a3d6-633331a85a34
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1074006
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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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 |
| August 4, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for DoubleDay Acquisitions dba CSAFE Global
- FDA Inspection 1215859 - 2023-07-25
- FDA Inspection 938778 - 2015-08-04
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