FDA Inspection
Guardian Angel Products IncGuardian Angel Products Inc – FDA Inspection, Aug 2, 2012
Record Details
This FDA Inspection record concerns Guardian Angel Products Inc, with an inspection on August 2, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Guardian Angel Products Inc
- Inspection Date
- August 2, 2012
- Product Type
- Devices
View Company Profile
ID · cc8dd5e2-666e-4531-9553-04e5e6860254
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 791767
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40(a)Document locations, Dissemination, etc.
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(h)Incorrect translation to production specifications
- 21 CFR 820.20(a)Quality policy and objectives
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Guardian Angel Products Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 11, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Guardian Angel Products Inc
- FDA Inspection 928618 - 2015-06-11
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.