FDA Inspection
Medline Industries - Arlington HeightsMedline Industries - Arlington Heights – FDA Inspection, May 28, 2014
Record Details
This FDA Inspection record concerns Medline Industries - Arlington Heights, with an inspection on May 28, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 28, 2014
- Product Type
- Devices
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ID · d800faa1-c412-4e39-b956-a580c38da277
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 881664
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.70(g)(2)Periodic equipment inspection lack of or inadequate procedu
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of Medline Industries - Arlington Heights
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2026 | Not classified | Chicago District Office | Compliance: Medical Devices |
| December 6, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 17, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 24, 2013 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 12, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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