FDA Inspection
Sphinx Tools LtdSphinx Tools Ltd – FDA Inspection, Aug 23, 2018
Record Details
This FDA Inspection record concerns Sphinx Tools Ltd, with an inspection on August 23, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Shaquenta Y. Perkins (Issuing Officer)
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ID · ad757045-10d2-461f-93a2-30f9c888e172
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065343
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.50Purchasing controls, 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 Sphinx Tools Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 18, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sphinx Tools Ltd
- FDA Inspection 1246761 - 2024-07-18
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