# FDA 483 - Herbrand PharmaChemicals GmbH - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/herbrand-pharmachemicals-gmbh/7df3eb4a-d334-4118-8fa2-3dde6a0d921a

> FDA 483 for Herbrand PharmaChemicals GmbH on Unknown Date. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Herbrand PharmaChemicals GmbH
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Herbrand PharmaChemicals GmbH, an API manufacturer in Gengenbach, Germany, revealed significant deficiencies in laboratory controls, data integrity, and record-keeping practices. Observations included a lack of audit trails on critical lab instruments, unauthorized access to testing functions, and inadequate control over batch production records and deviation tracking. These issues indicate a lack of assurance in the quality and purity of their raw materials, in-process materials, and APIs.

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

Company: https://www.globalkeysolutions.net/companies/herbrand-pharmachemicals-gmbh/7c4e489f-57d0-4d87-beff-712afa26b1e3

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