# FDA 483 - Wasserburger Arzneimittelwerk GmbH - Unknown Date

Source: https://www.keypedia.com/records/483/wasserburger-arzneimittelwerk-gmbh/605ba193-4e51-4e16-a6f5-135cc247611d

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

---

## Details

- Record Type: 483
- Company Name: Wasserburger Arzneimittelwerk GmbH
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: An FDA inspection of Wasserburg Arzneimittelwek GmbH (Recipharm) in Wasserburg a. Inn, Germany, a drug product manufacturer, identified significant deficiencies in the adherence to and adequacy of Standard Operating Procedures. The observations highlight issues across environmental monitoring, sanitization, material handling, labeling, and personnel segregation, indicating a systemic failure in maintaining controlled manufacturing operations. These findings suggest a moderate severity of non-compliance with established operational guidelines.

## Related Officers

- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)
- [Investigator](https://www.keypedia.com/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)

Company: https://www.keypedia.com/companies/wasserburger-arzneimittelwerk-gmbh/01756512-83f0-4432-8ab4-ea57cec1dfcc

Office: https://www.keypedia.com/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0