FDA Inspection
Intra-Lock International Inc.Intra-Lock International Inc. – FDA Inspection, Jul 2, 2010
Record Details
This FDA Inspection record concerns Intra-Lock International Inc., with an inspection on July 2, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 2, 2010
- Product Type
- Devices
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ID · f060b96a-1e2d-4dbf-b634-1010a3d319fb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 671040
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of Intra-Lock International Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 1, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 13, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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