# FDA 483 - Bioreliance Ltd. - September 27, 2019

Source: https://www.keypedia.com/records/483/bioreliance-ltd/ad0ac3f7-301c-407d-b274-68e2753f4c99

> FDA 483 for Bioreliance Ltd. on September 27, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bioreliance Ltd.
- Inspection Date: 2019-09-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Bioreliance Ltd. in Glasgow, United Kingdom, a manufacturer of API starting material and control testing laboratory, revealed three significant observations. These included failures to follow written sanitation procedures for equipment cleaning, deficiencies in aseptic simulations for operator qualification, and a lack of quality unit review for equipment changes or repairs during on-demand maintenance.

## 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 - Unknown Date](https://www.keypedia.com/records/483/bioreliance-ltd/0b5678c7-45aa-4a8a-bf45-d97d3036a471)
- [483 - Unknown Date](https://www.keypedia.com/records/483/bioreliance-ltd/dcd055b5-f47d-4abd-b927-177840723fab)

## Related Officers

- [Joey Y Quintana](https://www.keypedia.com/people/joey-y-quintana/f90686f9-accd-4034-825e-0adbd9203ff6)

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

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