Company
United StatesLone Star Medical Products, Inc., Stafford, TX – FDA Inspections
Inspection records and compliance data for Lone Star Medical Products, Inc. in Stafford, Texas. 6 FDA inspections on record (1 OAI), 1 Form 483, last inspected April 27, 2023.
Company Profile
This profile covers Lone Star Medical Products, Inc. based in Stafford, Texas, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 1
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected February 24, 2011. Last inspected April 27, 2023.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Documentation1 inspection
- Incorrect translation to production specifications1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 27, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1203824 |
| May 2, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1057460 |
| May 4, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1021325 |
| September 23, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 896250 |
| August 6, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 793298 |
| February 24, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 711363 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Lone Star Medical Products, Inc.
FEI Number
1627186
Address
11211 Cash Rd, Stafford, Texas 77477, United States
Country
United States
ID: 16f3ae83-de16-436d-a144-5d79b8660ec9