Warning letter
Pinnacle Labs of Tennessee, LLC dba Pinnacle BioLabs: warning letter of Apr 17, 2024
FDA warning letter 676367 · Center for Devices and Radiological Health
Key facts
| Reference number | 676367 |
|---|---|
| Company | Pinnacle Labs of Tennessee, LLC dba Pinnacle BioLabs |
| Subject | Medical Device/Misbranded |
| Issue date | Apr 17, 2024 |
| Posted date | Apr 30, 2024 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820, 807.3(d), 820.3, 807.81(b), 803, 803.17, 864.6550 |
| Inspection city | Nashville |
| Inspection ZIP | 37238 |
| Inspection start date | Oct 27, 2023 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: