Company
United StatesGenesis Biosystems, Inc - Inspection Records
Inspection records and compliance data for Genesis Biosystems, Inc in Lewisville, Texas. 5 FDA inspections on record (2 OAI), 1 Form 483, 1 warning letter, last inspected January 09, 2023.
Company Profile
This profile covers Genesis Biosystems, Inc based in Lewisville, Texas, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 2
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 1
First inspected June 27, 2013. Last inspected January 9, 2023.
Most cited issue areas
- Acceptable supplier records, inadequate records1 inspection
- Documentation1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 9, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1195256 |
| August 31, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1028385 |
| June 1, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 928343 |
| December 16, 2014 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 908043 |
| June 27, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 838279 |
FDA documents
Form 483s (1)
Warning Letters (1)
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Company Information
Name
Genesis Biosystems, Inc
FEI Number
3003427273
Address
1500 Eagle Ct, Lewisville, Texas 75057, United States
Country
United States
ID: 3e6cf839-9bf8-4efa-ab65-d78786001597