FDA Inspection
Respironics New Jersey, Inc.Respironics New Jersey, Inc. – FDA Inspection, May 15, 2009
Record Details
This FDA Inspection record concerns Respironics New Jersey, Inc., with an inspection on May 15, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Respironics New Jersey, Inc.
- Inspection Date
- May 15, 2009
- Product Type
- Devices
View Company Profile
ID · ca2123f3-edef-4e71-9dbd-5f07a4f0393d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 584465
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.100(a)(1)Analysis of data sources
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Respironics New Jersey, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Respironics New Jersey, Inc.
- FDA Inspection 769016 - 2012-02-27
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.