# FDA 483 - Bio Products Laboratory Ltd - August 30, 2022

Source: https://www.keypedia.com/records/483/bio-products-laboratory-ltd/024ec8b0-670d-419e-ba7b-cdf496ac2bf9

> FDA 483 for Bio Products Laboratory Ltd on August 30, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bio Products Laboratory Ltd
- Inspection Date: 2022-08-30
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: Bio Products Laboratory Ltd. in Elstree, United Kingdom, was cited for significant deficiencies during an FDA inspection from August 22-30, 2022. The observations primarily concern inadequate investigations into product failures, untimely reporting of biological product deviations, and critical failures in aseptic processing, environmental monitoring, and test method validation. These issues indicate a lack of adherence to established procedures and controls, potentially impacting product quality and patient safety.

## Related Officers

- [investigator](https://www.keypedia.com/people/priscilla-m-pastrana/170080d1-49da-42d7-8615-c774cac9f7ec)
- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

Company: https://www.keypedia.com/companies/bio-products-laboratory-ltd/6d68984a-5030-49c7-a826-12b37fa8d7d2

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321