Drug factory · FDA FEI 3005241015
CELLTRION Inc
23, Academy-ro, Yeonsu-gu, Incheon, South Korea
Problems found, fixed voluntarily at FDA's last inspection, May 3, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2015: 1 with no problems, 6 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Aflibercept | Makes the active ingredient and tests it | CELLTRION USA, Inc. | 72606-026 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 3, 2024 | Problems found, fixed voluntarily | Bioresearch Monitoring | 6 |
| May 3, 2024 | Problems found, fixed voluntarily | Bioresearch Monitoring | 6 |
| Feb 27, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 3, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 22, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jul 17, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 2, 2017 | Serious problems, FDA action | Drug Quality Assurance | — |
| Apr 9, 2015 | No problems found | 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.
May 3, 2024 inspection
- General responsibilities of sponsors 21 CFR 312.50
Failure to ensure proper monitoring of the study, ensure the study is conducted in accordance with the protocol and/or investigational plan and ensure that FDA and all investigators are promptly informed of significant new adverse effects or risks. - General responsibilities of sponsors 21 CFR 312.50
Failure to ensure proper monitoring of the study, ensure the study is conducted in accordance with the protocol and/or investigational plan and ensure that FDA and all investigators are promptly informed of significant new adverse effects or risks. - Review of Adverse Experiences - SOPs 21 CFR 600.80(b)
There are no written procedures for the surveillance, receipt and reporting of post-marketing adverse experiences to FDA. - Review of Adverse Experiences - SOPs 21 CFR 600.80(b)
There are no written procedures for the surveillance, receipt and reporting of post-marketing adverse experiences to FDA. - Reporting Requirements - submission of reports 21 CFR 600.80(c)(1)(iii)
Failure to submit each post marketing 15-day alert and post marketing 15-day alert follow up report as required. - Reporting Requirements - submission of reports 21 CFR 600.80(c)(1)(iii)
Failure to submit each post marketing 15-day alert and post marketing 15-day alert follow up report as required.
Oct 22, 2019 inspection
- Air Supply 21 CFR 211.42(c)(10)(iii)
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.