# FDA 483 - Bioreliance Ltd. - Unknown Date

Source: https://www.keypedia.com/records/483/bioreliance-ltd/dcd055b5-f47d-4abd-b927-177840723fab

> 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: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of BioReliance Limited in Glasgow, United Kingdom, revealed multiple deficiencies across its manufacturing and testing operations. Key issues included inadequate aseptic techniques leading to cross-contamination, untimely implementation of corrective actions, and failure to follow written sanitation procedures. The firm also had inadequate disinfectant effectiveness studies, incomplete investigation records, deficient batch production documentation, and insufficient media simulation studies.

## 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/0b5678c7-45aa-4a8a-bf45-d97d3036a471)

## 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/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd