# FDA 483 - Encore Medical, LP - December 08, 2023

Source: https://www.globalkeysolutions.net/records/483/encore-medical-lp/02a69cec-1061-4317-9d06-e0bfedf0cbad

> FDA 483 for Encore Medical, LP on December 08, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Encore Medical, LP
- Inspection Date: 2023-12-08
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Encore Medical, LP, a medical device manufacturer in Austin, TX, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant deficiencies in quality system processes, including failure to report a recall, inadequate acceptance activities, and systemic failures in corrective and preventive action procedures and risk analysis. These issues indicate a severe lack of control over manufacturing and quality processes, contributing to recurring product mix-ups and malfunctions.

## Related Documents

- [483 - 2021-10-28](https://www.globalkeysolutions.net/records/483/encore-medical-lp/d832f97d-a884-47da-961b-375fd06a1f58)

## Related Officers

- [Jacey Roy](https://www.globalkeysolutions.net/people/jacey-roy/6c4d5a32-4aa3-43b0-a06f-40757863219e)
- [James R. Montero](https://www.globalkeysolutions.net/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.globalkeysolutions.net/companies/encore-medical-lp/78cda835-589b-4868-9e95-be1e8d7b9b4c

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