# FDA 483 - DDC Technologies, Inc. - June 28, 2019

Source: https://www.keypedia.com/records/483/ddc-technologies-inc/4fd9a793-a27d-4994-9de2-62bf2ad9f6ad

> FDA 483 for DDC Technologies, Inc. on June 28, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DDC Technologies, Inc.
- Inspection Date: 2019-06-28
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: DDC Technologies Inc., a manufacturer of laser hair removal devices in Oceanside, NY, was cited for numerous quality system deficiencies during an FDA inspection. The observations primarily concerned the lack of established procedures for design control, design changes, environmental controls, equipment calibration, and quality audits. Several issues, including inadequate device history records and design change procedures, were repeat observations from a previous inspection, indicating significant and persistent non-compliance.

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## 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