Drug factory · FDA FEI 3005709762
Bushu Pharmaceuticals, Ltd.
1 Takeno, Kawagoe, Japan
Problems found, fixed voluntarily at FDA's last inspection, Aug 3, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2010: 0 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Lansoprazole | Makes it and tests it | Takeda Pharmaceuticals America, Inc. | 64764-046 |
| Nirsevimab | Tests it | Sanofi Vaccines US Inc. | 49281-574, 49281-575 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 3, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Dec 2, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Sep 16, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 25, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 15, 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.
Aug 3, 2026 inspection
- Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not established that describe the in-process controls to be conducted on appropriate samples of in-process materials of each batch. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
Dec 2, 2022 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures and laboratory control mechanisms are not followed and documented at the time of performance. - 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 and fully followed. - Defined areas of adequate size for operations 21 CFR 211.42(c)
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
Registered with FDA for: analysis; label; manufacture; pack.