FDA Inspection
Neo Medical, Inc.Neo Medical, Inc. – FDA Inspection, Mar 26, 2010
Record Details
This FDA Inspection record concerns Neo Medical, Inc., with an inspection on March 26, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Neo Medical, Inc.
- Inspection Date
- March 26, 2010
- Product Type
- Devices
View Company Profile
ID · 9f28ae55-ec2c-4c14-a413-8b382aa14a83
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 656609
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.70(g)(2)Periodic equipment inspection lack of or inadequate procedu
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Neo Medical, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 13, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 3, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 18, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 25, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Neo Medical, Inc.
- FDA Inspection 898228 - 2014-09-12
- FDA Inspection 866276 - 2014-02-13
- FDA Inspection 751437 - 2011-11-03
- FDA Inspection 660098 - 2009-09-18
- FDA Inspection 580901 - 2009-03-25
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