Warning letter
The Richline Group, Inc.: warning letter of Aug 25, 2025
FDA warning letter 712818 · Center for Devices and Radiological Health
Key facts
| Reference number | 712818 |
|---|---|
| Company | The Richline Group, Inc. |
| Subject | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| Issue date | Aug 25, 2025 |
| Posted date | Sep 23, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 801.20(a), 807.81(b), 820, 801, 801.3, 801.40(a)(1), 801.40(a)(2), 803.12(a), 830, 830.3, 830.300(a) |
| Inspection city | Tamarac |
| Inspection ZIP | 33321 |
| Inspection start date | Mar 24, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
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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: