# FDA 483 - Bioreliance Ltd. - Unknown Date

Source: https://www.keypedia.com/records/483/bioreliance-ltd/0b5678c7-45aa-4a8a-bf45-d97d3036a471

> FDA 483 for Bioreliance Ltd. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bioreliance Ltd.
- Product Type: biologics
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of BioReliance Limited in Glasgow, Scotland, revealed numerous deficiencies across equipment, facilities, quality systems, and laboratory controls. The firm failed to maintain equipment in a qualified and calibrated state, exhibited unreliable data in its equipment tracking system, and had inadequate storage space. Significant issues were also noted in timely corrective action implementation, client notification of deviations, and environmental monitoring practices, indicating a lack of robust quality oversight.

## 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)
- [483 - 2019-09-27](https://www.keypedia.com/records/483/bioreliance-ltd/ad0ac3f7-301c-407d-b274-68e2753f4c99)
- [483 - Unknown Date](https://www.keypedia.com/records/483/bioreliance-ltd/dcd055b5-f47d-4abd-b927-177840723fab)

## Related Officers

- [Cynthia Jim](https://www.keypedia.com/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)

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