Company
United StatesHyperox Inc, Langhorne, PA – FDA Inspections
Inspection records and compliance data for Hyperox Inc in Langhorne, Pennsylvania. 1 FDA inspection on record, last inspected January 28, 2009.
Company Profile
This profile covers Hyperox Inc based in Langhorne, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected January 28, 2009.
Most cited issue areas
- Design history file1 inspection
- Installer"s documentation of results1 inspection
- Lack of or inadequate DHR procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 28, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 643381 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Hyperox Inc
FEI Number
3005683281
Address
447 Woodbourne Rd, Langhorne, Pennsylvania 19047, United States
Country
United States
ID: d843d9b5-5d52-43bc-9749-1d6543ea1208