FDA Inspection
Pinnacle Biologics IncPinnacle Biologics Inc – FDA Inspection, Apr 30, 2019
Record Details
This FDA Inspection record concerns Pinnacle Biologics Inc, with an inspection on April 30, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pinnacle Biologics Inc
- Inspection Date
- April 30, 2019
- Product Type
- Devices
View Company Profile
ID · caed5eba-c524-4818-a65d-ba654360bfed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1088192
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(d)Evaluation, timeliness, identification
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 |
| June 27, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 1172994 - 2022-06-27
- FDA Inspection 958308 - 2016-03-15
- FDA Inspection 866408 - 2014-02-11
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.