FDA Inspection
Fort Worth Eye Prosthetics, IncFort Worth Eye Prosthetics, Inc – FDA Inspection, Jun 3, 2011
Record Details
This FDA Inspection record concerns Fort Worth Eye Prosthetics, Inc, with an inspection on June 3, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 3, 2011
- Product Type
- Devices
View Company Profile
ID · 30cb9a0f-fe37-4e4b-a1c1-8d0b5df7f453
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 732245
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.198(a)Complaints
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(e)Quality System Procedures
- 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.