# FDA 483 - Aesculap AG - July 16, 2015

Source: https://www.globalkeysolutions.net/records/483/aesculap-ag/b51131f0-d04a-490b-b69a-86f258c0f835

> FDA 483 for Aesculap AG on July 16, 2015. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aesculap AG
- Inspection Date: 2015-07-16
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Aesculap AG, a device manufacturer in Tuttlingen, Germany, was inspected by the FDA from July 13-16, 2015. The inspection revealed a significant issue regarding the timely submission of Medical Device Reports (MDRs). Specifically, the firm failed to submit MDRs within 30 days for multiple complaints involving device malfunctions that could lead to death or serious injury if they recurred.

## Related Officers

- [Lydia S. Chan](https://www.globalkeysolutions.net/people/lydia-s-chan/72222ce5-67b5-41f9-abfa-6de8f001104d)

Company: https://www.globalkeysolutions.net/companies/aesculap-ag/7bf23acc-23fe-4733-bd67-2e0736286f2f

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