# Terumo BCT Ltd – FDA 483, Jun 26, 2026

Source: https://www.keypedia.com/records/483/terumo-bct-ltd/972b3d7b-62fc-45c2-a678-81aa72b6b558

> FDA 483 for Terumo BCT Ltd on June 26, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Terumo BCT Ltd
- Inspection Date: 2026-06-26
- Product Type: biologics
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Terumo BCT Ltd, a biological drug manufacturer in Larne, United Kingdom, revealed two significant observations related to laboratory control. The firm failed to adequately document calculations for final product release testing and did not consistently record or investigate deviations from written specifications, impacting drug products distributed to the United States.

## Related Documents

- [483 - 2023-01-19](https://www.keypedia.com/records/483/terumo-bct-ltd/774fa042-c438-4f18-a2c4-e24d7f9d5d70) — date: January 19, 2023
- [483 - 2020-02-07](https://www.keypedia.com/records/483/terumo-bct-ltd/d1d35841-2276-447f-b925-99e1e87434a8) — date: February 7, 2020

## Related Officers

- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

Company: https://www.keypedia.com/companies/terumo-bct-ltd/182a5d92-4c5c-4393-95cd-45250ca7eb25

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8