Drug factory · FDA FEI 3002808311
Takeda Pharmaceutical Company Limited
2-17-85, Jusohonmachi, , Yodogawa-Ku, Japan
No problems found at FDA's last inspection, Apr 12, 2024.
No Action Indicated: inspectors found no objectionable conditions.
7 drug inspections on record since 2010: 2 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dexlansoprazole | Makes it and tests it | TWi Pharmaceuticals, Inc. | 24979-703, 24979-704 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 12, 2024 | No problems found | Drug Quality Assurance | — |
| Aug 9, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Aug 29, 2017 | No problems found | Drug Quality Assurance | — |
| Sep 18, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 6, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Aug 2, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 14, 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 9, 2019 inspection
- Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not justified. - Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - 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.
Sep 6, 2013 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established. - Test methods 21 CFR 211.165(e)
The accuracy and sensitivity of test methods have not been established and documented. - 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. - 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.
Registered with FDA for: analysis; manufacture; pack.