Company
United StatesPinnacle Biologics Inc, Bannockburn, IL – FDA Inspections
Inspection records and compliance data for Pinnacle Biologics Inc in Bannockburn, Illinois. 5 FDA inspections on record, 2 Form 483s, last inspected June 13, 2025.
Company Profile
This profile covers Pinnacle Biologics Inc based in Bannockburn, Illinois, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected February 11, 2014. Last inspected June 13, 2025.
Most cited issue areas
- Individual Report of Malfunction3 inspections
- Evaluation, timeliness, identification2 inspections
- Lack of Written MDR Procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 13, 2025 | NAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1272551 |
| June 27, 2022 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1172994 |
| April 30, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1088192 |
| March 15, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 958308 |
| February 11, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 866408 |
FDA documents
Form 483s (2)
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Company Information
Name
Pinnacle Biologics Inc
FEI Number
3010119152
Address
2801 Lakeside Dr Ste 210, Bannockburn, Illinois 60015, United States
Country
United States
ID: c497d9fb-e403-4095-8c90-3607e789a5f1