Drug factory · FDA FEI 3002870748
Takeda Ireland Limited
Bray South Business Park Killarney Road, Bray, Ireland
Problems found, fixed voluntarily at FDA's last inspection, Dec 9, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2009: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Azilsartan | Makes it, tests it, packages it and labels it | Wilshire Pharmaceuticals Inc. | 52536-004, 52536-008 |
| Brigatinib | Makes it, tests it, packages it and labels it | Takeda Pharmaceuticals America, Inc. | 63020-090, 63020-113, 63020-180 +1 |
| Dexlansoprazole | Makes it and tests it | TWi Pharmaceuticals, Inc., Takeda Pharmaceuticals America, Inc. | 24979-703, 24979-704, 64764-171 +1 |
| Maribavir | Makes it, tests it, packages it and labels it | Takeda Pharmaceuticals America, Inc. | 64764-800 |
| Ponatinib | Makes it, tests it, packages it and labels it | Takeda Pharmaceuticals America, Inc. | 63020-533, 63020-534, 63020-535 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 9, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 28, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 27, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Mar 2, 2016 | No problems found | Drug Quality Assurance | — |
| Dec 20, 2012 | No problems found | Drug Quality Assurance | — |
| Apr 30, 2009 | 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.
Apr 27, 2018 inspection
- 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. - Suitability of testing methods verified 21 CFR 211.194(a)(2)
The suitability of all testing methods is not verified under actual conditions of use. - 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. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine checking of mechanical equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: analysis; label; manufacture; pack.