Company
United StatesStrukmyer LLC, Mesquite, TX – FDA Inspections
Inspection records and compliance data for Strukmyer LLC in Mesquite, Texas. 4 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected September 06, 2024.
Company Profile
This profile covers Strukmyer LLC based in Mesquite, Texas, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected June 9, 2016. Last inspected September 6, 2024.
Most cited issue areas
- Components withheld from use pending release1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 6, 2024 | Not classified | Medical Devices & Rad Health | 1249285 |
| August 1, 2024 | OAI | Human Drugs · Drug Quality Assurance | 1245694 |
| May 25, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1053279 |
| June 9, 2016 | VAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 977306 |
FDA documents
Form 483s (1)
Warning Letters (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Strukmyer LLC
FEI Number
3000205837
Address
1801 Big Town Blvd Ste 100, Mesquite, Texas 75149, United States
Country
United States
ID: e88a21a5-5cb3-44cb-be17-5ae442aee17e