# FDA 483 - BLV licht- und Vakuumtechnik GmbH - August 23, 2019

Source: https://www.keypedia.com/records/483/blv-licht-und-vakuumtechnik-gmbh/ca99a354-e456-4381-88ca-80c23a2130de

> FDA 483 for BLV licht- und Vakuumtechnik GmbH on August 23, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BLV licht- und Vakuumtechnik 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, revealed six significant quality system deficiencies. The firm lacked adequate procedures for statistical techniques, process validation, in-process product acceptance, and control of nonconforming materials. Repeat observations highlighted ongoing issues with corrective and preventive actions and insufficient device history records.

## Related Officers

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

Company: https://www.keypedia.com/companies/blv-licht-und-vakuumtechnik-gmbh/d0e279bd-df41-4f6f-9664-595d104f3287

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