# FDA 483 - USHIO GERMANY GmbH - August 23, 2019

Source: https://www.keypedia.com/records/483/ushio-germany-gmbh/0d590c6e-f752-4291-9b83-c7fa44462593

> FDA 483 for USHIO GERMANY GmbH on August 23, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: USHIO GERMANY GmbH
- Inspection Date: 2019-08-23
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of BLV licht- und Vakuumtechnik GmbH, a UV Lamp manufacturer in Steinhoring, Bavaria, Germany, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for statistical techniques, process validation, in-process product acceptance, nonconforming product control, and corrective and preventive actions. Several observations, including issues with process validation and CAPA, were repeats from a previous inspection, indicating persistent quality control problems.

## Related Officers

- [Matthew D. Schnittker](https://www.keypedia.com/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.keypedia.com/companies/ushio-germany-gmbh/9331ee4d-d19a-4851-9de3-948e3f24a47a

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