# FDA 483 - DDC Technologies, Inc. - October 22, 2021

Source: https://www.keypedia.com/records/483/ddc-technologies-inc/292aec29-380e-43fc-af5f-99e4539940f5

> FDA 483 for DDC Technologies, Inc. on October 22, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: DDC Technologies, Inc.
- Inspection Date: 2021-10-22
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of DDC Technologies Inc. in Oceanside, NY, a manufacturer of medical laser devices, revealed significant deficiencies in quality system documentation and regulatory reporting. The firm failed to adequately maintain device history records, document incoming product acceptance, and submit required product and annual reports for its laser devices. These observations indicate a need for improved adherence to medical device regulations.

## Related Documents

- [483 - 2019-06-28](https://www.keypedia.com/records/483/ddc-technologies-inc/4fd9a793-a27d-4994-9de2-62bf2ad9f6ad)
- [483 - 2020-01-08](https://www.keypedia.com/records/483/ddc-technologies-inc/5a2de023-fd36-41ca-813f-dc9191574e36)
- [483 - 2024-09-06](https://www.keypedia.com/records/483/ddc-technologies-inc/e8fd474f-2850-4455-84c0-a1e31356464c)

## Related Officers

- [Andrew J. Garufi](https://www.keypedia.com/people/andrew-j-garufi/567f6aaa-f6f2-45a3-9a58-80b33f3ad021)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961