FDA Inspection
Home Care Technology USA IncHome Care Technology USA Inc – FDA Inspection, Aug 18, 2011
Record Details
This FDA Inspection record concerns Home Care Technology USA Inc, with an inspection on August 18, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Home Care Technology USA Inc
- Inspection Date
- August 18, 2011
- Product Type
- Devices
View Company Profile
ID · f8245f30-28ff-40a8-819b-681ea4e60703
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 740048
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Home Care Technology USA Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Home Care Technology USA Inc
- FDA Inspection 798191 - 2012-09-11
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.