Company
United StatesErgoMed, Inc., San Antonio, TX – FDA Inspections
Inspection records and compliance data for ErgoMed, Inc. in San Antonio, Texas. 4 FDA inspections on record, 1 Form 483, last inspected December 06, 2023.
Company Profile
This profile covers ErgoMed, Inc. based in San Antonio, Texas, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 4
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected August 23, 2019. Last inspected December 6, 2023.
Most cited issue areas
- Lack of procedures, or not maintained2 inspections
- Purchasing controls, Lack of or inadequate procedures2 inspections
- Quality audits - Lack of or inadequate procedures2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 6, 2023 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1224604 |
| October 5, 2022 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1181395 |
| November 5, 2021 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1156173 |
| August 23, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1101119 |
FDA documents
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
ErgoMed, Inc.
FEI Number
1000306115
Address
6511 Amber Oak, San Antonio, Texas 78249, United States
Country
United States
ID: 5e741b64-904e-40af-a99e-beaee2784b70