FDA Inspection
Defense Health Clinical SystemsDefense Health Clinical Systems – FDA Inspection, Nov 12, 2014
Record Details
This FDA Inspection record concerns Defense Health Clinical Systems, with an inspection on November 12, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 12, 2014
- Product Type
- Devices
View Company Profile
ID · ff2b772a-7ed3-4cc4-b301-f267cda53007
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 900167
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
14- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.30(j)Design history file
Showing 10 of 14 citations.
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.