FDA Inspection
So-Low Environmental Equipment Co. Inc.So-Low Environmental Equipment Co. Inc. – FDA Inspection, Apr 17, 2013
Record Details
This FDA Inspection record concerns So-Low Environmental Equipment Co. Inc., with an inspection on April 17, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 17, 2013
- Product Type
- Devices
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ID · 3b89c237-b8fd-4f3b-b45e-cd6647144102
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 827715
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
13- 21 CFR 820.80(e)Documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
Showing 10 of 13 citations.
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Other FDA inspections of So-Low Environmental Equipment Co. Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 14, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 21, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for So-Low Environmental Equipment Co. Inc.
- FDA Inspection 874358 - 2014-04-14
- FDA Inspection 606852 - 2009-08-21
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