Drug factory · FDA FEI 3008356774
Eisai Manufacturing Ltd
Mosquito Way, Hatfield, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Jan 21, 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 2010: 0 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Donepezil | Makes it and tests it | Eisai Inc. | 62856-245, 62856-246 |
| Eribulin | Tests it, packages it and labels it | Eisai Inc. | 62856-389 |
| Lemborexant | Makes it and tests it | Eisai Inc. | 62856-405, 62856-410, 62856-455 |
| Perampanel | Makes it | Eisai Inc. | 62856-272, 62856-274, 62856-276 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 21, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 1, 2019 | Problems found, fixed voluntarily | Bioresearch Monitoring | 1 |
| Nov 29, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 13, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jul 12, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 23, 2010 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 1, 2019 inspection
- General responsibilities of sponsors 21 CFR 312.50
Failure to ensure the study is conducted in accordance with the protocol and/or investigational plan.
May 13, 2016 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Registered with FDA for: analysis; label; manufacture; pack.