# FDA 483 - Karl Storz SE & Co. KG - March 12, 2020

Source: https://www.keypedia.com/records/483/karl-storz-se-co-kg/3ee24cfc-d62e-44c9-ad4f-3835f53577e6

> FDA 483 for Karl Storz SE & Co. KG on March 12, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Karl Storz SE & Co. KG
- Inspection Date: 2020-03-12
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Karl Storz SE & Co. KG, a medical device manufacturer in Tuttlingen, Germany, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for complaint handling, ensure service reports contained all required information, and control environmental conditions related to electrical energy. These issues indicate systemic problems in maintaining compliance with regulatory requirements.

## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/karl-storz-se-co-kg/9a3c2a81-9936-4f85-bc12-6ac095561af9

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