# FDA 483 - Epicare Acquisitions, Llc - February 10, 2022

Source: https://www.keypedia.com/records/483/epicare-acquisitions-llc/9db1fc4d-1714-4271-a68c-beef99877209

> FDA 483 for Epicare Acquisitions, Llc on February 10, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Epicare Acquisitions, Llc
- Inspection Date: 2022-02-10
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Epicare Acquisitions, Llc in Lawrenceville, NJ, was inspected by the FDA, resulting in three observations. The inspection revealed significant deficiencies in device history records, including incomplete testing and review, as well as inadequate documentation of design verification results for laser devices. Additionally, the firm lacked established procedures for identifying training needs and documenting personnel training.

## Related Documents

- [483 - 2024-12-13](https://www.keypedia.com/records/483/epicare-acquisitions-llc/7d99ceaf-b8b4-43f4-9c5d-e13923ac4563)
- [WARNING_LETTER - 2024-12-13](https://www.keypedia.com/records/warning_letter/epicare-acquisitions-llc/e9147315-88b3-4ce0-988f-1a05aab3e07f)

## Related Officers

- [William R. Chang](https://www.keypedia.com/people/william-r-chang/67893bac-29e2-45b4-ba2c-1ef548781b9c)

Company: https://www.keypedia.com/companies/epicare-acquisitions-llc/00ff358c-1f18-422c-bdfb-b620f91674f6

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248