FDA Inspection
Frantz Design, IncFrantz Design, Inc – FDA Inspection, Mar 5, 2009
Record Details
This FDA Inspection record concerns Frantz Design, Inc, with an inspection on March 5, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Frantz Design, Inc
- Inspection Date
- March 5, 2009
- Product Type
- Devices
View Company Profile
ID · 127f6a4a-cda1-42a4-b9e2-5b7eea2697e7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 568730
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
15- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.198(a)General
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.20Management responsibility
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(e)Maintained
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