FDA Inspection
Orbital Therapy LLCOrbital Therapy LLC – FDA Inspection, Mar 26, 2010
Record Details
This FDA Inspection record concerns Orbital Therapy LLC, with an inspection on March 26, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Orbital Therapy LLC
- Inspection Date
- March 26, 2010
- Product Type
- Devices
View Company Profile
ID · 796c440a-f012-49d7-ae40-8341c03b0c99
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 659763
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.30(b)Establish the design and development plan
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.70(a)(1)Process control instructions
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Orbital Therapy LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 23, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Orbital Therapy LLC
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.