FDA Inspection
Microline Surgical, Inc.Microline Surgical, Inc. – FDA Inspection, Feb 25, 2010
Record Details
This FDA Inspection record concerns Microline Surgical, Inc., with an inspection on February 25, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Microline Surgical, Inc.
- Inspection Date
- February 25, 2010
- Product Type
- Devices
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ID · 2c77ef12-2fec-4f53-9d4d-9a64365a962d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 651460
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)General
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.100(b)Procedures
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Other FDA inspections of Microline Surgical, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 21, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 8, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Microline Surgical, Inc.
- FDA Inspection 854105 - 2013-09-18
- FDA Inspection 736554 - 2011-07-21
- FDA Inspection 709060 - 2011-02-08
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