# FDA 483 - Haupt Pharma Muenster GmbH - July 06, 2018

Source: https://www.keypedia.com/records/483/haupt-pharma-muenster-gmbh/e06ebb4d-b570-4c24-ae58-d40d5dbe6135

> FDA 483 for Haupt Pharma Muenster GmbH on July 06, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Haupt Pharma Muenster GmbH
- Inspection Date: 2018-07-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Haupt Pharma Muenster GmbH in Munster, Germany, revealed significant deficiencies in their quality control unit, including inadequate failure investigations and stability testing reviews. The firm also lacked appropriate controls over electronic data systems, compromising data integrity, and failed to establish written procedures for critical production and process controls, particularly for contract analytical testing. These observations indicate a need for comprehensive improvements in their quality management system.

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Company: https://www.keypedia.com/companies/haupt-pharma-muenster-gmbh/09cdc4cc-6cbc-4904-baa2-d4013dae9741

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