FDA Inspection
Armstrong Industries, Inc dba Sterling Medical TechnologiesArmstrong Industries, Inc dba Sterling Medical Technologies – FDA Inspection, Aug 5, 2010
Record Details
This FDA Inspection record concerns Armstrong Industries, Inc dba Sterling Medical Technologies, with an inspection on August 5, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 5, 2010
- Product Type
- Devices
View Company Profile
ID · 632a2605-4115-441b-b5ec-7d0c6a3740d5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 674273
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.198(a)Complaints
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
Showing 10 of 11 citations.
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Other FDA inspections of Armstrong Industries, Inc dba Sterling Medical Technologies
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 23, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 15, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Armstrong Industries, Inc dba Sterling Medical Technologies
- FDA Inspection 887871 - 2014-07-21
- FDA Inspection 833189 - 2013-05-23
- FDA Inspection 753679 - 2011-11-15
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