Company
United StatesPrestige Ameritech, North Richland Hills, TX – FDA Inspections
Inspection records and compliance data for Prestige Ameritech in North Richland Hills, Texas. 4 FDA inspections on record, 2 Form 483s, last inspected January 11, 2024.
Company Profile
This profile covers Prestige Ameritech based in North Richland Hills, Texas, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected November 13, 2014. Last inspected January 11, 2024.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Lack of System for Timely Submission of Reports1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 11, 2024 | Not classified | Medical Devices & Rad Health | 1227701 |
| March 27, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1084042 |
| August 20, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1063422 |
| November 13, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 903287 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Prestige Ameritech
FEI Number
3005022483
Address
7201 Iron Horse Blvd, North Richland Hills, Texas 76180, United States
Country
United States
ID: 0f0334bc-35d8-4eb8-b7a8-b994b7c55727