FDA Inspection
Aubrey IncAubrey Inc – FDA Inspection, Feb 4, 2011
Record Details
This FDA Inspection record concerns Aubrey Inc, with an inspection on February 4, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Aubrey Inc
- Inspection Date
- February 4, 2011
- Product Type
- Devices
View Company Profile
ID · d9e2e363-f1c8-4e19-95a8-c9086a7375c5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 709661
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
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.