FDA Inspection
Pinnacle Biologics IncPinnacle Biologics Inc – FDA Inspection, Jun 27, 2022
Record Details
This FDA Inspection record concerns Pinnacle Biologics Inc, with an inspection on June 27, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pinnacle Biologics Inc
- Inspection Date
- June 27, 2022
- Product Type
- Devices
View Company Profile
ID · 6d68642e-3e85-4ad7-8353-c440e47d4055
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1172994
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.198(b)Review and evaluation for investigation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Pinnacle Biologics Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2025 | NAI | Chicago District Office | Compliance: Medical Devices |
| April 30, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 15, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 11, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Pinnacle Biologics Inc
- FDA Inspection 1272551 - 2025-06-13
- FDA Inspection 1088192 - 2019-04-30
- FDA Inspection 958308 - 2016-03-15
- FDA Inspection 866408 - 2014-02-11
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