FDA Inspection
Action Products IncorporatedAction Products Incorporated – FDA Inspection, Dec 7, 2017
Record Details
This FDA Inspection record concerns Action Products Incorporated, with an inspection on December 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c932486f-d798-4f00-8020-c6ef2ba003ee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034224
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Action Products Incorporated
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 11, 2025 | Not classified | Baltimore District Office | |
| September 19, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 9, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Action Products Incorporated
- FDA Inspection 1272601 - 2025-06-11
- FDA Inspection 896217 - 2014-09-19
- FDA Inspection 740562 - 2011-08-09
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