# FDA 483 - Contract Medical International GmbH - May 11, 2023

Source: https://www.globalkeysolutions.net/records/483/contract-medical-international-gmbh/62fbbba8-f58e-4693-8bf5-bba6e4136fc6

> FDA 483 for Contract Medical International GmbH on May 11, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Contract Medical International GmbH
- Inspection Date: 2023-05-11
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Contract Medical International GmbH, a class II medical device manufacturer located in Dresden, Germany, identified one observation. The firm was cited for not adequately establishing procedures for the acceptance and control of in-process product, indicating a deficiency in their quality control system.

## Related Officers

- [Cso](https://www.globalkeysolutions.net/people/daniel-j-lahar/d4e329c0-b6a5-42ca-acde-b79413b245ea)

Company: https://www.globalkeysolutions.net/companies/contract-medical-international-gmbh/a0391078-b0d7-46c2-9e70-1ede6c113dc5

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