# FDA 483 - Millipore (U.K.) Ltd. - February 27, 2020

Source: https://www.keypedia.com/records/483/millipore-uk-ltd/ffe29c45-c2bf-4244-bbbe-054d2ab64edd

> FDA 483 for Millipore (U.K.) Ltd. on February 27, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Millipore (U.K.) Ltd.
- Inspection Date: 2020-02-27
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: An FDA inspection of Millipore (U.K.) Ltd., a licensed bulk blood grouping reagent manufacturer in Livingston, United Kingdom, revealed two significant observations. The firm was cited for releasing licensed products before completing conformity tests, specifically regarding sodium azide content, and for failing to maintain adequate records to trace manufacturing steps, including unreviewed calculations and assessments in batch records.

## Related Officers

- [Program Expert for Advanced Manufacturing ](https://www.keypedia.com/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)
- [Regulatory Project Manager](https://www.keypedia.com/people/nimmy-mathews/9eac44d1-5e4c-493a-89c5-c7414a5a4037)

Company: https://www.keypedia.com/companies/millipore-uk-ltd/41adcbfa-b3ff-4c4c-beb1-8b5e6d1fca7f

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