Biotech companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Celltrion and its 2 subsidiaries with 13 drug applications, 7 complete response letters, 5 device recalls and 2 warning letters. The most recent is a complete response letter dated Mar 26, 2025: Complete response letter, BLA 761377.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Celltrion and its 2 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 26, 2025 | Complete response letter, BLA 761377Unapproved | Complete response letters |
| Sep 30, 2024 | Complete response letter, BLA 761338Approved | Complete response letters |
| Jun 27, 2024 | Complete response letter, BLA 761377Unapproved | Complete response letters |
| Nov 23, 2022 | Complete response letter, BLA 761219Approved | Complete response letters |
| Apr 1, 2022 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02Class I · Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID. | Device recalls |
| Feb 25, 2022 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02Class II · Kits were labeled with incorrect expiration dates. | Device recalls |
| Dec 28, 2021 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02Class I · The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kit | Device recalls |
| Dec 2, 2021 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02Class I · Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional | Device recalls |
| Dec 1, 2021 | Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sClass II · The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally | Device recalls |
| Nov 24, 2021 | Complete response letter, BLA 761219Approved | Complete response letters |
| Sep 17, 2018 | Warning letter: DrugsCDER | Warning letters |
| Mar 30, 2018 | Complete response letter, BLA 761091Approved | Complete response letters |
| Feb 28, 2018 | Complete response letter, BLA 761088Approved | Complete response letters |
| Jan 26, 2018 | Warning letter: Aseptic processing, Sterility assurance, StabilityCDER | Warning letters |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
