FDA Inspection
So-Low Environmental Equipment Co. Inc.So-Low Environmental Equipment Co. Inc. – FDA Inspection, Aug 21, 2009
Record Details
This FDA Inspection record concerns So-Low Environmental Equipment Co. Inc., with an inspection on August 21, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 21, 2009
- Product Type
- Devices
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ID · d93f48be-6463-4058-888e-a82eb0d58c13
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 606852
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
13- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.200(d)No Service reports
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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 |
| April 17, 2013 | OAI | 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 827715 - 2013-04-17
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