FDA Inspection
Sklar InstrumentsSklar Instruments – FDA Inspection, Sep 30, 2011
Record Details
This FDA Inspection record concerns Sklar Instruments, with an inspection on September 30, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sklar Instruments
- Inspection Date
- September 30, 2011
- Product Type
- Devices
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ID · 0b362f0e-0797-4fe3-be9a-8bb107320777
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 747975
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR content
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Other FDA inspections of Sklar Instruments
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2018 | Not classified | Philadelphia District Office | |
| August 3, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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