# FDA 483 - Nordmark Arzneimittel GMBH & Co. KG - February 13, 2017

Source: https://www.keypedia.com/records/483/nordmark-arzneimittel-gmbh-co-kg/eef74cad-0c2c-43b0-bf4b-3616c0a31761

> FDA 483 for Nordmark Arzneimittel GMBH & Co. KG on February 13, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nordmark Arzneimittel GMBH & Co. KG
- Inspection Date: 2017-02-13
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Nordmark Arzneimittel GmbH & Co. KG in Utersen, Germany, received a Form 483 following a February 2017 inspection. Observations included failures in equipment maintenance plans, the use of un-validated electronic records for critical manufacturing calculations, and inadequate routine monitoring for cleaning validation of non-dedicated equipment. These issues indicate significant concerns regarding quality control and data integrity in drug substance and product manufacturing.

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Company: https://www.keypedia.com/companies/nordmark-arzneimittel-gmbh-co-kg/871eb270-8517-4646-923a-b4d2eb0ea73b

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