# FDA 483 - Merz Pharma Gmbh & Co. KGaA - June 10, 2022

Source: https://www.keypedia.com/records/483/merz-pharma-gmbh-co-kgaa/dd70029d-85b3-41a3-acb3-e1d2337f9752

> FDA 483 for Merz Pharma Gmbh & Co. KGaA on June 10, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merz Pharma Gmbh & Co. KGaA
- Inspection Date: 2022-06-10
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Merz Pharma GmbH & Co. KGaA in Reinheim, Germany, was inspected by the FDA from June 7-10, 2022. The inspection resulted in one observation regarding inadequate procedures for controlling non-conforming products. Specifically, the firm's procedures for processing time requirements were not adequately established.

## Related Officers

- [Dedicated Device Cadre](https://www.keypedia.com/people/dedicated-device-cadre/693932db-dd86-453f-9b51-a63444b07281)
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Company: https://www.keypedia.com/companies/merz-pharma-gmbh-co-kgaa/13d354e3-eaae-4a18-aee1-47d9e8ce916a

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd