Drug factory · FDA FEI 3002807834
Otsuka Pharmaceutical Co Ltd
HIRAISHIEBISUNO224-18, KAWAUCHICHO, Tokushima, Japan
Problems found, fixed voluntarily at FDA's last inspection, Mar 22, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2011: 0 with no problems, 7 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Tolvaptan | Makes the active ingredient and tests it | Otsuka America Pharmaceutical, Inc. | 59148-079, 59148-080, 59148-082 +4 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 22, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Sep 10, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 23, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 12, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 26, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 9, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 27, 2011 | 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.
Mar 22, 2024 inspection
- Deviations from laboratory control requirements 21 CFR 211.160(a)
Deviations from written sampling plans are not justified. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - Reports of Analysis (Components) 21 CFR 211.84(d)(2)
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component.
Registered with FDA for: analysis; api manufacture; manufacture.