Drug factory · FDA FEI 1000071265
Diversified Chemical Products
60 Germay Drive, Wilmington, DE, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 31, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2013: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ferric Cation | Makes it | Gynex Corporation, Premier Dental Products Company | 48992-001, 48783-112, 48783-113 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 31, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 25, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jun 28, 2013 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Oct 25, 2017 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing. - Cleaning/maintenance records not kept 21 CFR 211.67(c)
Records are not kept for the inspection of equipment.
Registered with FDA for: label; manufacture; pack.