Company
United StatesModal Manufacturing, LLC, Richardson, TX – FDA Inspections
Inspection records and compliance data for Modal Manufacturing, LLC in Richardson, Texas. 3 FDA inspections on record, 2 Form 483s, last inspected December 08, 2017.
Company Profile
This profile covers Modal Manufacturing, LLC based in Richardson, Texas, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 3
- Form 483s
- 2
- Warning letters
- 0
First inspected February 15, 2017. Last inspected December 8, 2017.
Most cited issue areas
- Lack of or inadequate process validation2 inspections
- Purchasing controls, Lack of or inadequate procedures2 inspections
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 8, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1034573 |
| August 8, 2017 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1026893 |
| February 15, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1003096 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Modal Manufacturing, LLC
FEI Number
3011685200
Address
1565 N Central Expy Ste 240, Richardson, Texas 75080, United States
Country
United States
ID: 3c081d54-5d79-400c-8f20-02f0db6f2c2f