FDA Inspection
Intra-Lock International Inc.Intra-Lock International Inc. – FDA Inspection, May 1, 2017
Record Details
This FDA Inspection record concerns Intra-Lock International Inc., with an inspection on May 1, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d99d1b02-8f12-4ec8-88f9-f0f2e2925cb0
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1012884
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Intra-Lock International Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 2, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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