FDA Inspection
Creation Technologies LTDCreation Technologies LTD – FDA Inspection, Aug 16, 2018
Record Details
This FDA Inspection record concerns Creation Technologies LTD, with an inspection on August 16, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Creation Technologies LTD
- Inspection Date
- August 16, 2018
- Product Type
- Medical Devices & Rad Health
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ID · c86d89c6-2b77-4c81-83ee-419af0d71657
Inspection Facts
- Inspection number
- 1062953
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.90(a)Nonconforming product control
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Other FDA inspections of Creation Technologies LTD
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 9, 2023 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 5, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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