# FDA 483 - Merz Pharma GmbH & Co., KGaA - November 22, 2019

Source: https://www.globalkeysolutions.net/records/483/merz-pharma-gmbh-co-kgaa/f531c972-160a-4e9f-97ff-9b11868ea634

> FDA 483 for Merz Pharma GmbH & Co., KGaA on November 22, 2019. 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: 2019-11-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Merz Pharma GmbH & Co., KGaA, a drug substance and drug product manufacturer in Dessau-Rosslau, Germany, revealed significant deficiencies. Observations included failures to submit biological deviation reports for stopper particles, inadequate establishment of test method accuracy, and scientifically unsound laboratory controls for in-process materials. Additionally, the firm failed to follow written production and process control procedures for visual operator qualification.

## Related Officers

- [Yumi Hiramine](https://www.globalkeysolutions.net/people/yumi-hiramine/26c5059f-8f61-42cf-ae79-65a7b942d2c7)
- [Microbiologist](https://www.globalkeysolutions.net/people/susan-t-hadman/512c3274-4da8-4f5a-a081-965ab5ec84e6)

Company: https://www.globalkeysolutions.net/companies/merz-pharma-gmbh-co-kgaa/758203de-10f2-4cff-a0ca-d3b1152277c0

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