FDA Inspection
Superex Canada LtdSuperex Canada Ltd – FDA Inspection, Jan 22, 2013
Record Details
This FDA Inspection record concerns Superex Canada Ltd, with an inspection on January 22, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Superex Canada Ltd
- Inspection Date
- January 22, 2013
- Product Type
- Devices
View Company Profile
ID · 8f0a7cb9-5242-46ef-987a-8e9700e6bfb1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 815275
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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.