Warning letter
North American Diagnostics, LLC: warning letter of Dec 27, 2022
FDA warning letter 643203 · Center for Devices and Radiological Health
Key facts
| Reference number | 643203 |
|---|---|
| Company | North American Diagnostics, LLC |
| Subject | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| Issue date | Dec 27, 2022 |
| Posted date | Apr 18, 2023 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 820 |
| Inspection city | Holly Hill |
| Inspection ZIP | 32117-3604 |
| Inspection start date | Jun 14, 2022 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- 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: