Drug factory · FDA FEI 3002545766
Terumo BCT Ltd
Old Belfast Road, Millbrook, Larne, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Feb 11, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2011: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Anhydrous Citric Acid | Makes it, tests it, labels it and sterilizes it | Terumo BCT, Ltd. | 14537-881, 14537-883 |
| Anhydrous Citric Acid and Anhydrous Dextrose | Makes it, tests it, packages it, labels it and sterilizes it | Terumo BCT, Ltd. | 14537-810, 14537-815, 14537-817 |
| Anhydrous Citric Acid and Anhydrous Dextrose and Sodium Cation | Makes it, tests it, labels it and sterilizes it | Arteriocyte Medical Systems, Inc., Terumo BCT, Ltd. | 43203-852, 14537-820, 14537-967 |
| Dexmedetomidine | Makes it, tests it, packages it and labels it | Hospira, Inc. | 0409-0155, 0409-4596 |
| Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosp | Makes it, tests it, labels it and sterilizes it | Terumo BCT, Ltd. | 14537-824, 14537-826, 14537-828 +4 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 11, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 11, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 28, 2016 | No problems found | Drug Quality Assurance | — |
| Mar 28, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| May 12, 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 28, 2014 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - Deviations from laboratory control requirements 21 CFR 211.160(a)
Deviations from written test procedures are not justified. - Following/documenting laboratory controls 21 CFR 211.160(a)
Established sampling plans, test procedures, and laboratory control mechanisms are not followed and documented at the time of performance. - 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 in writing and fully followed.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.