FDA Inspection
Shanghai Xodus Medical Company LimitedShanghai Xodus Medical Company Limited – FDA Inspection, Jul 11, 2019
Record Details
This FDA Inspection record concerns Shanghai Xodus Medical Company Limited, with an inspection on July 11, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Teresa K. Kastner
View Company Profile
ID · af204d91-a891-4c97-b7df-1fd5375a1e63
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1099708
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.80(e)Documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 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(a)Process control procedures, Lack of or inadequate procedures
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.