FDA Inspection
LAR NE, LLCLAR NE, LLC – FDA Inspection, Sep 1, 2015
Record Details
This FDA Inspection record concerns LAR NE, LLC, with an inspection on September 1, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- LAR NE, LLC
- Inspection Date
- September 1, 2015
- Product Type
- Devices
View Company Profile
ID · a0dddbd1-fb35-4945-b5af-96926ce11755
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 940282
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.80(c)Documentation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of LAR NE, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 28, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 4, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for LAR NE, LLC
- FDA Inspection 986147 - 2016-09-28
- FDA Inspection 748469 - 2011-10-04
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