Warning letter
Health-Chem Diagnostics, LLC: warning letter of Dec 7, 2017
FDA warning letter 526232 · Florida District Office
Key facts
| Reference number | 526232 |
|---|---|
| Company | Health-Chem Diagnostics, LLC |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Dec 7, 2017 |
| Posted date | Dec 19, 2017 |
| Issuing office | Florida District Office |
| Product type | Devices |
| CFR sections cited | 807.81(b) |
| Inspection city | Pompano Beach |
| Inspection ZIP | 33069 |
| Inspection start date | Jan 23, 2017 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- VAI 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: