Company
United StatesAXENA HEALTH, INC., Auburndale, MA – FDA Inspections
Inspection records and compliance data for AXENA HEALTH, INC. in Auburndale, Massachusetts. 1 FDA inspection on record, 1 Form 483, last inspected November 14, 2018.
Company Profile
This profile covers AXENA HEALTH, INC. based in Auburndale, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected November 14, 2018.
Most cited issue areas
- Design review - Lack of or inadequate procedures1 inspection
- Management review - Lack of or inadequate procedures1 inspection
- Quality audits - Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 14, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1071637 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
AXENA HEALTH, INC.
FEI Number
3026585193
Address
2120 Commonwealth Ave Ste 1, Auburndale, Massachusetts 02466, United States
Country
United States
ID: 591c8b4f-6a0b-41d6-9a7e-55c70094c01c