Company
United StatesInnovative Surgical Designs, Inc., Bloomington, IN – FDA Inspections
Inspection records and compliance data for Innovative Surgical Designs, Inc. in Bloomington, Indiana. 3 FDA inspections on record (1 OAI), 2 Form 483s, last inspected April 26, 2018.
Company Profile
This profile covers Innovative Surgical Designs, Inc. based in Bloomington, Indiana, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected August 27, 2015. Last inspected April 26, 2018.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Lack of or inadequate procedures2 inspections
- Design Validation - Risk analysis not performed/inadequate1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 26, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1049811 |
| July 27, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1019901 |
| August 27, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 940153 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Innovative Surgical Designs, Inc.
FEI Number
3010586931
Address
3903 S Walnut St, Bloomington, Indiana 47401, United States
Country
United States
ID: e63d60b0-e0b2-43e1-87d0-bd8181cbaac6