Company
United StatesQuality Bioresources, Inc, Seguin, TX – FDA Inspections
Inspection records and compliance data for Quality Bioresources, Inc in Seguin, Texas. 3 FDA inspections on record, 1 Form 483, last inspected December 19, 2024.
Company Profile
This profile covers Quality Bioresources, Inc based in Seguin, Texas, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected January 13, 2017. Last inspected December 19, 2024.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Batch production and Batch Control Record Requirements1 inspection
- Strict control not exercised over labeling issued1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 19, 2024 | Not classified | Biologics · Blood and Blood Products | 1256997 |
| August 29, 2019 | Not classified | Medical Devices & Rad Health | 1102959 |
| January 13, 2017 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1000894 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Quality Bioresources, Inc
FEI Number
1000117860
Address
1015 N Austin St, Seguin, Texas 78155, United States
Country
United States
ID: 3fa63e69-7126-4059-9bfb-cea6b26ecb7f