Drug factory · FDA FEI 3002809299
Otsuka Pharmaceutical Co Ltd
KAGASUNO463-10, KAWAUCHICHO, Tokushima, Japan
No problems found at FDA's last inspection, May 16, 2025.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2012: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Tolvaptan | Makes it and tests it | Otsuka America Pharmaceutical, Inc. | 59148-079, 59148-080, 59148-082 +4 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 16, 2025 | No problems found | Drug Quality Assurance | — |
| Oct 10, 2019 | No problems found | Drug Quality Assurance | — |
| Dec 8, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 15, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 18, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 2, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
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 2, 2012 inspection
- Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established. - 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. - Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used and description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance.
Registered with FDA for: analysis; manufacture.