# FDA 483 - Aesculap Inc - August 11, 2021

Source: https://www.globalkeysolutions.net/records/483/aesculap-inc/46300e90-9d01-48f2-bcd0-2636d6a63be8

> FDA 483 for Aesculap Inc on August 11, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aesculap Inc
- Inspection Date: 2021-08-11
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Aesculap Implant Systems LLC in Center Valley, PA, revealed significant deficiencies in their quality system. The firm failed to submit Medical Device Reports (MDRs) within the required timeframe and did not maintain proper written MDR procedures. Additionally, the evaluation of critical suppliers was not adequately documented.

## Related Officers

- [Investigator at US Food and Drug Administration](https://www.globalkeysolutions.net/people/brian-s-keefer/4fec578b-ca72-4d79-8634-3a9fe7ecd9a5)

Company: https://www.globalkeysolutions.net/companies/aesculap-inc/d29d14e6-1cfa-415e-8172-44ad4aa1b329

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8