# FDA 483 - Siegfried PharmaChemikalien Minden Gmbh - March 04, 2019

Source: https://www.keypedia.com/records/483/siegfried-pharmachemikalien-minden-gmbh/05a7d180-9d74-4cfe-bf69-aa2016b9f0e3

> FDA 483 for Siegfried PharmaChemikalien Minden Gmbh on March 04, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Siegfried PharmaChemikalien Minden Gmbh
- Inspection Date: 2019-03-04
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Siegfried PharmaChemikalien Minden GmbH in Minden, Germany, from March 4-8, 2019, revealed a significant issue in their production system. The firm was cited for failing to properly identify equipment with batch and cleaning status, including instances of undocumented cleaning. This indicates a lapse in control over manufacturing processes for API production.

## Related Officers

- [Consumer Safety Officer (Drug Specialist)](https://www.keypedia.com/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)

Company: https://www.keypedia.com/companies/siegfried-pharmachemikalien-minden-gmbh/711ac70f-e753-40c0-92fd-687cb4eeecc2

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