# FDA 483 - Haupt Pharma Wolfratshausen GmbH - November 12, 2026

Source: https://www.keypedia.com/records/483/haupt-pharma-wolfratshausen-gmbh/3d2176e8-778c-4c00-b21d-cc2f2c541ec0

> FDA 483 for Haupt Pharma Wolfratshausen GmbH on November 12, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Haupt Pharma Wolfratshausen GmbH
- Inspection Date: 2026-11-12
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Haupt Pharma Wolfratshausen GmbH, a sterile drug manufacturer in Germany, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate cleaning and environmental monitoring in aseptic processing areas, deficient personnel monitoring, and failures in qualification of labeling and packaging lines. Additionally, the firm failed to perform required microbiological and particulate testing on stoppers and did not validate supplier Certificates of Analysis for these materials.

## Related Officers

- [Jeremy W. Rotten](https://www.keypedia.com/people/jeremy-w-rotten/a46c2864-ac44-4533-a919-3d4f993d5acc)
- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.keypedia.com/companies/haupt-pharma-wolfratshausen-gmbh/c95278bf-619e-48d6-965b-308ac8af4620

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