Company
United StatesIsto Biologics, Saint Louis, MO – FDA Inspections
Inspection records and compliance data for Isto Biologics in Saint Louis, Missouri. 3 FDA inspections on record, last inspected September 17, 2018.
Company Profile
This profile covers Isto Biologics based in Saint Louis, Missouri, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 18, 2011. Last inspected September 17, 2018.
Most cited issue areas
- Design plans - Lack of or inadequate1 inspection
- Management review - Lack of or inadequate procedures1 inspection
- Nonconforming product control1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 17, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1067144 |
| June 15, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 786221 |
| February 18, 2011 | VAI | Biologics, Medical Devices & Rad Health · Human Cellular, Tissue, and Gene Therapies | 710391 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Isto Biologics
FEI Number
3005610160
Address
477 N Lindbergh Blvd Ste 225, Saint Louis, Missouri 63141, United States
Country
United States
ID: 12c079c3-689d-45c6-8400-e1a0024e59ae