Company
United StatesXhale Assurance, Inc., Andover, MA – FDA Inspections
Inspection records and compliance data for Xhale Assurance, Inc. in Andover, Massachusetts. 2 FDA inspections on record, 1 Form 483, last inspected April 05, 2019.
Company Profile
This profile covers Xhale Assurance, Inc. based in Andover, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 21, 2013. Last inspected April 5, 2019.
Most cited issue areas
- Purchasing controls, Lack of or inadequate procedures2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 5, 2019 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1085814 |
| November 21, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 857325 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Xhale Assurance, Inc.
FEI Number
3010150334
Address
3000 Minuteman Rd, Andover, Massachusetts 01810, United States
Country
United States
ID: df617e83-d5a2-4bc7-92ae-8ba116089841