Drug factory · FDA FEI 2515379
Dentsply Caulk
38 West Clarke Avenue, Milford, DE, United States
No problems found at FDA's last inspection, Mar 5, 2024.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2009: 4 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Benzocaine | Makes it | NDC, Inc., SmartHealth, Inc. (DBA SmartPractice) | 43128-020, 43128-021, 43128-022 +9 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 5, 2024 | No problems found | Drug Quality Assurance | — |
| Jul 22, 2016 | No problems found | Drug Quality Assurance | — |
| Aug 9, 2011 | No problems found | Drug Quality Assurance | — |
| Sep 16, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: manufacture.