FDA Inspection
Safety Medical International, Inc.Safety Medical International, Inc. – FDA Inspection, Feb 6, 2009
Record Details
This FDA Inspection record concerns Safety Medical International, Inc., with an inspection on February 6, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 6, 2009
- Product Type
- Devices
View Company Profile
ID · b2d0bfc7-ae5d-4629-a971-edc53e42486d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 560769
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.70(b)Verification or validation of changes
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - documentation
- 21 CFR 820.30(g)Design validation - simulated testing
- 21 CFR 820.40(a)Document review, approval documentation
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
Full citation text and observation details available on the Dashboard.
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.