# FDA 483 - Customed, Inc. - October 04, 2024

Source: https://www.keypedia.com/records/483/customed-inc/d2ce28b3-b02b-4d35-be09-a9793db2ef84

> FDA 483 for Customed, Inc. on October 04, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Customed, Inc.
- Inspection Date: 2024-10-04
- Product Type: device
- Office Name: San Juan District Office
- Summary: Customed, Inc., a manufacturer of Class 2 medical devices in Fajardo, PR, was cited for significant quality system deficiencies. The inspection revealed failures in controlling non-conforming products, including manufacturing in out-of-spec temperatures and using expired sterile barrier components. Additionally, the firm did not adequately implement its corrective and preventive action procedures, nor did it properly handle product storage conditions for critical components.

## Related Documents

- [WARNING_LETTER - 2014-07-31](https://www.keypedia.com/records/warning_letter/customed-inc/43c31d7c-15fe-4558-a56f-5a822319a33d)
- [483 - 2023-04-18](https://www.keypedia.com/records/483/customed-inc/06968d1f-39db-4176-881f-06c8a02c4997)

## 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/customed-inc/1b2cbb33-6103-4c40-827f-e944ed2f56b2

Office: https://www.keypedia.com/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8