Drug factory · FDA FEI 3007378821
Sumika Chemical Analysis Service, Ltd.
2200 Oazatsurusaki, Oita, Japan
No problems found at FDA's last inspection, Nov 7, 2025.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2010: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Lidocaine | Tests it | MEDRx USA, Inc. | 83708-111 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 7, 2025 | No problems found | Drug Quality Assurance | — |
| Nov 13, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jun 22, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 12, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 24, 2012 | No problems found | Drug Quality Assurance | — |
| Jul 30, 2010 | Problems found, fixed voluntarily | 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.
Nov 13, 2019 inspection
- Backup data not assured as exact and complete 21 CFR 211.68(b)
Backup data is not assured as secure from alteration, erasure or loss through keeping hard copy or alternate systems.
Registered with FDA for: analysis.