Company
United StatesOrbital Therapy LLC, Bedford, MA – FDA Inspections
Inspection records and compliance data for Orbital Therapy LLC in Bedford, Massachusetts. 2 FDA inspections on record, last inspected October 23, 2012.
Company Profile
This profile covers Orbital Therapy LLC based in Bedford, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected March 26, 2010. Last inspected October 23, 2012.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- DHR - not or inadequately maintained1 inspection
- Establish the design and development plan1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 23, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 804902 |
| March 26, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 659763 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Orbital Therapy LLC
FEI Number
3006796102
Address
8 Alfred Cir, Bedford, Massachusetts 01730, United States
Country
United States
ID: 904795ee-254d-4e19-8a3c-62557426c45c