FDA Inspection
International Medical Industries, Inc.International Medical Industries, Inc. – FDA Inspection, Apr 3, 2018
Record Details
This FDA Inspection record concerns International Medical Industries, Inc., with an inspection on April 3, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4de1dea8-7846-4b55-9665-ab4ba4f21377
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1046687
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(h)Incorrect translation to production specifications
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
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Other FDA inspections of International Medical Industries, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 18, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 11, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for International Medical Industries, Inc.
- FDA Inspection 952332 - 2015-12-18
- FDA Inspection 782777 - 2012-05-11
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