# FDA 483 - Ensemble Orthopedics, Inc. - August 04, 2023

Source: https://www.keypedia.com/records/483/ensemble-orthopedics-inc/c24ffae5-fd21-4a21-9d7d-31cb4228b5a8

> FDA 483 for Ensemble Orthopedics, Inc. on August 04, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ensemble Orthopedics, Inc.
- Inspection Date: 2023-08-04
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Ensemble Orthopedics, Inc. in West Lake Hills, TX, was inspected from August 1-4, 2023, and received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning corrective and preventive actions, complaint handling, supplier qualification, and quality audit procedures. These issues indicate a lack of adequate control over critical manufacturing processes and record-keeping.

## Related Officers

- [Monica C. Burgos Garcia](https://www.keypedia.com/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)

Company: https://www.keypedia.com/companies/ensemble-orthopedics-inc/cb327bb9-1c4a-438a-8119-0a66321f64f9

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab