FDA Inspection 1172994 — Pinnacle Biologics Inc
The FDA completed an inspection of Pinnacle Biologics Inc on June 27, 2022 in Bannockburn, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 27, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bannockburn, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |