Warning letter
Dental Technologies Inc.: warning letter of Nov 30, 2021
FDA warning letter 612599 · Division of Pharmaceutical Quality Operations III
Key facts
| Reference number | 612599 |
|---|---|
| Company | Dental Technologies Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Nov 30, 2021 |
| Posted date | Dec 14, 2021 |
| Issuing office | Division of Pharmaceutical Quality Operations III |
| Product type | Drugs |
| CFR sections cited | 820, 211.34, 211.63, 211.160, 211.192, 211.100(a), 211.160(b) |
| Inspection city | Lincolnwood |
| Inspection ZIP | 60712 |
| Inspection start date | Dec 7, 2020 |
| 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: