FDA Inspection
Shanghai Chien Ti Motor Co., Ltd.Shanghai Chien Ti Motor Co., Ltd. – FDA Inspection, Jun 19, 2014
Record Details
This FDA Inspection record concerns Shanghai Chien Ti Motor Co., Ltd., with an inspection on June 19, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 19, 2014
- Product Type
- Devices
View Company Profile
ID · eaf97df5-4767-4bf1-827c-1ef419ceb0a5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 887467
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Shanghai Chien Ti Motor Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 26, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Shanghai Chien Ti Motor Co., Ltd.
- FDA Inspection 631543 - 2009-11-26
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.