# FDA 483 - DDC Technologies, Inc. - January 08, 2020

Source: https://www.keypedia.com/records/483/ddc-technologies-inc/5a2de023-fd36-41ca-813f-dc9191574e36

> FDA 483 for DDC Technologies, Inc. on January 08, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DDC Technologies, Inc.
- Inspection Date: 2020-01-08
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: DDC Technologies Inc. in Oceanside, NY, received a Form FDA 483 with three repeat observations during an inspection from January 6-8, 2020. The firm was cited for inadequate procedures regarding design changes, environmental controls in the production area, and management reviews. These findings indicate significant deficiencies in the company's quality system for manufacturing laser devices.

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## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

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