# FDA 483 - Dermal Photonic Corp - July 18, 2019

Source: https://www.keypedia.com/records/483/dermal-photonic-corp/052b5476-bf2a-4ddf-add6-ae631a2e2a56

> FDA 483 for Dermal Photonic Corp on July 18, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dermal Photonic Corp
- Inspection Date: 2019-07-18
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: DERMAL PHOTONICS CORPORATION in Peabody, MA, a medical device manufacturer, was cited for significant deficiencies in its design control procedures. The inspection revealed a lack of established procedures for design output and design transfer, as well as inadequate documentation of design verification results for its Nira Laser product. These issues indicate a moderate level of non-compliance with quality system regulations.

## Related Officers

- [Nabil Nakhoul](https://www.keypedia.com/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

Company: https://www.keypedia.com/companies/dermal-photonic-corp/d995fd7e-9bc2-4e57-bf6f-df36619561df

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94