# FDA 483 - ZIMMER BIOMET dba Embody, Inc. - August 18, 2023

Source: https://www.keypedia.com/records/483/zimmer-biomet-dba-embody-inc/017c5609-89cd-4ed9-912a-fa1d089beaa2

> FDA 483 for ZIMMER BIOMET dba Embody, Inc. on August 18, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ZIMMER BIOMET dba Embody, Inc.
- Inspection Date: 2023-08-18
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of ZIMMER BIOMET dba Embody, Inc. in Norfolk, VA, revealed significant deficiencies in their quality system. The firm failed to adequately establish and implement procedures for finished device acceptance, including incoming inspection, and also had inadequate procedures for receiving, reviewing, and evaluating complaints, leading to insufficient investigations of device malfunctions.

## Related Officers

- [Tiki Dixon](https://www.keypedia.com/people/tiki-dixon/b3160a2c-ef16-4fa2-b9b9-4c3a0ed17c5b)

Company: https://www.keypedia.com/companies/zimmer-biomet-dba-embody-inc/d89d4aaa-b169-4ede-a2c6-7d26a9bb4d16

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64