# FDA 483 - Bioreliance Ltd. - December 05, 2025

Source: https://www.keypedia.com/records/483/bioreliance-ltd/c87e74bb-34fe-4329-aab5-9c578962c664

> FDA 483 for Bioreliance Ltd. on December 05, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bioreliance Ltd.
- Inspection Date: 2025-12-05
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Bioreliance Ltd. in Glasgow, a drug substance manufacturer, received a Form 483 citing three significant observations. The firm failed to adequately investigate out-of-specification bioburden test results for an Adenovirus Type 7 batch, which was released to the U.S. market. Additionally, deficiencies were noted in material storage, inventory control, and aseptic practices during bulk filling operations.

## Related Documents

- [483 - 2016-03-23](https://www.keypedia.com/records/483/bioreliance-ltd/65cfa852-a580-44df-b51d-02d411ba7ddd)
- [EIR - 2017-09-22](https://www.keypedia.com/records/eir/bioreliance-ltd/9dd77080-9912-4672-bf23-6692cfc07b17)
- [EIR - 2019-03-15](https://www.keypedia.com/records/eir/bioreliance-ltd/c035ae5c-c719-463e-87d6-d1af3010c1b5)
- [483 - 2019-09-27](https://www.keypedia.com/records/483/bioreliance-ltd/ad0ac3f7-301c-407d-b274-68e2753f4c99)
- [EIR - 2019-09-27](https://www.keypedia.com/records/eir/bioreliance-ltd/3c24bf4a-1400-4924-9a48-479ed85a811e)

## Related Officers

- [Travis S. Bradley](https://www.keypedia.com/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)
- [Lewis K. Antwi](https://www.keypedia.com/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)

Company: https://www.keypedia.com/companies/bioreliance-ltd/fec1a160-db6a-4ebc-9632-aa6e2996e17e

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