# FDA 483 - Asteelflash Design Solutions Hamburg GmbH - May 09, 2019

Source: https://www.globalkeysolutions.net/records/483/asteelflash-design-solutions-hamburg-gmbh/b143df3a-9825-4374-86ca-4575eef5b88c

> FDA 483 for Asteelflash Design Solutions Hamburg GmbH on May 09, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Asteelflash Design Solutions Hamburg GmbH
- Inspection Date: 2019-05-09
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Arteelflash Design Solutions Hamburg GmbH, a contract manufacturer of LED medical devices, was cited for multiple quality system deficiencies during an FDA inspection. Observations included inadequate validation of a manufacturing process, insufficient CAPA procedures lacking effectiveness verification, and failures in document control. Additionally, the firm's environmental control and employee training procedures were found to be inadequately established.

## Related Officers

- [Stephen R. Souza](https://www.globalkeysolutions.net/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

Company: https://www.globalkeysolutions.net/companies/asteelflash-design-solutions-hamburg-gmbh/ec81d0ac-6595-4ed4-81c0-872c5ab5d7f4

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