FDA Inspection
Top Safety Products Company, Inc.Top Safety Products Company, Inc. – FDA Inspection, Apr 24, 2018
Record Details
This FDA Inspection record concerns Top Safety Products Company, Inc., with an inspection on April 24, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 81d0f89d-33c7-4d99-9f68-ed6d4d28f7f8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1049378
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Top Safety Products Company, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 9, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Top Safety Products Company, Inc.
- FDA Inspection 576661 - 2009-04-09
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