# FDA 483 - Lyocontract GmbH - September 20, 2019

Source: https://www.keypedia.com/records/483/lyocontract-gmbh/e60440bc-39ae-47d9-99fd-47a918e9bd2f

> FDA 483 for Lyocontract GmbH on September 20, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lyocontract GmbH
- Inspection Date: 2019-09-20
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Lyocontract GmbH, a contract drug manufacturer in Ilsenburg (Harz), Germany, revealed significant deficiencies in laboratory controls. Observations included inadequate validation of test methods, insufficient documentation of testing procedures, and incomplete records for laboratory reference standards. These issues indicate a lack of robust quality control in their analytical operations.

## Related Documents

- [EIR - 2019-09-20](https://www.keypedia.com/records/eir/lyocontract-gmbh/3d53a783-f6e6-4509-a433-f501ffdd7382)

## Related Officers

- [Pharmaceutical Program Expert](https://www.keypedia.com/people/zachary-l-stamm/b729fab9-4d31-4c70-b5b3-e8b6207769c6)

Company: https://www.keypedia.com/companies/lyocontract-gmbh/0c56698a-6a88-4c94-9de9-6e9f5172cf27

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