# FDA 483 - Terumo BCT Ltd - February 07, 2020

Source: https://www.globalkeysolutions.net/records/483/terumo-bct-ltd/d1d35841-2276-447f-b925-99e1e87434a8

> FDA 483 for Terumo BCT Ltd on February 07, 2020. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Terumo BCT Ltd
- Inspection Date: 2020-02-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Terumo BCT Ltd, a sterile parenteral manufacturer in Larne, United Kingdom, was cited for significant deficiencies during an FDA inspection. Observations included failures in following procedures to prevent microbiological contamination, specifically regarding sterilization validation processes and disinfectant efficacy studies. Additionally, the firm's batch production and control records were found to be incomplete, lacking essential in-process bioburden test results and review instructions.

## Related Documents

- [483 - 2023-01-19](https://www.globalkeysolutions.net/records/483/terumo-bct-ltd/774fa042-c438-4f18-a2c4-e24d7f9d5d70)

## Related Officers

- [Santos E. Camara](https://www.globalkeysolutions.net/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1