# FDA 483 - Aesculap Implant Systems LLC - June 08, 2021

Source: https://www.globalkeysolutions.net/records/483/aesculap-implant-systems-llc/6e7a4592-9d99-4a72-9ae5-fe62e537feff

> FDA 483 for Aesculap Implant Systems LLC on June 08, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aesculap Implant Systems LLC
- Inspection Date: 2021-06-08
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: Aezculap Implant Systems LLC in Breinigsville, PA, was inspected by the FDA from June 7-8, 2021, resulting in one observation. The inspection found that the firm failed to document evaluations of out-of-calibration equipment and remedial actions. This indicates a lapse in quality system documentation for critical manufacturing equipment.

## 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-implant-systems-llc/f8c60868-dbdf-4e2b-9bd7-5e5b4ff046ee

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