FDA Inspection
AOTI Ltd.AOTI Ltd. – FDA Inspection, Apr 22, 2010
Record Details
This FDA Inspection record concerns AOTI Ltd., with an inspection on April 22, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- AOTI Ltd.
- Inspection Date
- April 22, 2010
- Product Type
- Devices
View Company Profile
ID · 286455d0-9386-48a7-b31c-467d548c71d7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 661652
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.184(e)ID label, labeling
- 21 CFR 820.100(b)Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of AOTI Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 20, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for AOTI Ltd.
- FDA Inspection 1038662 - 2017-07-20
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.