Drug factory · FDA FEI 3008808597
Element Materials Technology Ann Arbor LLC
4840 Venture Dr., Ann Arbor, MI, United States
No problems found at FDA's last inspection, Feb 23, 2026.
No Action Indicated: inspectors found no objectionable conditions.
3 drug inspections on record since 2016: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Naloxone | Tests it | Uswm, LLC | 78670-140 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 23, 2026 | No problems found | Drug Quality Assurance | — |
| Sep 9, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jun 28, 2016 | 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.
Sep 9, 2022 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: analysis.