# FDA 483 - DDC Technologies, Inc. - September 06, 2024

Source: https://www.keypedia.com/records/483/ddc-technologies-inc/e8fd474f-2850-4455-84c0-a1e31356464c

> FDA 483 for DDC Technologies, Inc. on September 06, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DDC Technologies, Inc.
- Inspection Date: 2024-09-06
- Product Type: device
- Office Name: New York District Office
- Summary: DDC Technologies, Inc. in Oceanside, NY, a manufacturer of medical laser systems, was cited for five observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning design controls, acceptance activities, CAPA, environmental controls, and complaint handling. These issues indicate a lack of adequate procedures and documentation to ensure product quality and regulatory compliance.

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## Related Officers

- [Jacqueline S. Warner](https://www.keypedia.com/people/jacqueline-s-warner/d001f4ec-db46-4d78-a5dd-efea7ddfb893)

Company: https://www.keypedia.com/companies/ddc-technologies-inc/00fd8fb0-c959-4db1-83b5-b6d4685c67c5

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d