# FDA 483 - Customed, Inc. - April 18, 2023

Source: https://www.keypedia.com/records/483/customed-inc/06968d1f-39db-4176-881f-06c8a02c4997

> FDA 483 for Customed, Inc. on April 18, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Customed, Inc.
- Inspection Date: 2023-04-18
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Customed, Inc. in Fajardo, PR, a manufacturer of medical devices, revealed significant deficiencies in their quality system. The firm failed to adequately control non-conforming products, including not initiating field actions for known component issues, and conducted inadequate complaint investigations. Additionally, observations noted non-adherence to sterile manufacturing gowning procedures and a complete lack of internal audits and management reviews for the year 2022.

## Related Documents

- [WARNING_LETTER - 2014-07-31](https://www.keypedia.com/records/warning_letter/customed-inc/43c31d7c-15fe-4558-a56f-5a822319a33d)
- [483 - 2024-10-04](https://www.keypedia.com/records/483/customed-inc/d2ce28b3-b02b-4d35-be09-a9793db2ef84)

## Related Officers

- [Adaliz Santaliz-Cruz](https://www.keypedia.com/people/adaliz-santaliz-cruz/47bd4220-e6cc-4582-a4f5-bd4337f92622)

Company: https://www.keypedia.com/companies/customed-inc/1b2cbb33-6103-4c40-827f-e944ed2f56b2

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6