Warning letter
Exer Labs, Inc.: warning letter of Feb 10, 2025
FDA warning letter 699218 · Center for Devices and Radiological Health
Key facts
| Reference number | 699218 |
|---|---|
| Company | Exer Labs, Inc. |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Issue date | Feb 10, 2025 |
| Posted date | Mar 25, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820, 807.81(b), 890.9(a), 890.5360 |
| Inspection city | Denver |
| Inspection ZIP | 80218 |
| Inspection start date | Oct 17, 2024 |
| 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: