# FDA 483 - Aesculap Inc - October 30, 2019

Source: https://www.keypedia.com/records/483/aesculap-inc/ce23b678-4e21-4660-9a07-aeb4b4cd0ec2

> FDA 483 for Aesculap Inc on October 30, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Aesculap Inc
- Inspection Date: 2019-10-30
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Aesculap Inc. in Hazelwood, MO, was inspected from October 21-30, 2019, and received a Form FDA 483 with nine observations. The inspection revealed significant deficiencies across its quality system, including inadequate corrective and preventive actions, unvalidated processes, and failures in medical device reporting. These issues indicate a systemic breakdown in ensuring device quality, safety, and regulatory compliance.

## Related Documents

- [483 - 2018-06-13](https://www.keypedia.com/records/483/aesculap-inc/84d3fe67-45a3-4d41-95c4-3f0f3841c6c0)

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)
- [Supervisory](https://www.keypedia.com/people/kathleen-b-swat/8bbaa25d-cf50-4da5-8b6c-ce32df24e978)
- [investigator](https://www.keypedia.com/people/michelle-j-glembin/e58f4652-d09f-41a7-941d-335c7b5338ad)

Company: https://www.keypedia.com/companies/aesculap-inc/40479973-1b19-440a-8e8c-5aeec6c45a29

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8