Warning letter
Dunagin Pharmaceuticals Inc. dba Massco Dental: warning letter of Feb 22, 2023
FDA warning letter 644335 · Division of Pharmaceutical Quality Operations II
Key facts
| Reference number | 644335 |
|---|---|
| Company | Dunagin Pharmaceuticals Inc. dba Massco Dental |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Feb 22, 2023 |
| Posted date | Mar 21, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations II |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.22(a), 211.42(c), 211.84(d)(2), 211.100(a), 211.160(b) |
| Inspection city | Rogers |
| Inspection ZIP | 72756 |
| Inspection start date | Aug 29, 2022 |
| 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: