FDA Inspection
APC Medical, Ltd.APC Medical, Ltd. – FDA Inspection, Sep 22, 2011
Record Details
This FDA Inspection record concerns APC Medical, Ltd., with an inspection on September 22, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- APC Medical, Ltd.
- Inspection Date
- September 22, 2011
- Product Type
- Devices
View Company Profile
ID · 5e5443fe-182a-4d34-a637-df9d05fc8d92
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 748982
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(c)Service reports/MDRs/complaints
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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.