# FDA 483 - Sunrise Pharmaceutical, Inc. - January 18, 2018

Source: https://www.globalkeysolutions.net/records/483/sunrise-pharmaceutical-inc/4159c34f-3efa-482e-9f9e-dc63c25cccb2

> FDA 483 for Sunrise Pharmaceutical, Inc. on January 18, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sunrise Pharmaceutical, Inc.
- Inspection Date: 2018-01-18
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Sunrise Pharmaceutical, Inc. in Rahway, NJ, revealed a significant deficiency in their quality system. The firm failed to conduct ongoing GMP training for approximately (b)(4) employees involved in production, packaging, and quality control operations. This indicates a lack of assurance that employees are familiar with current Good Manufacturing Practice requirements.

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- [Yvesna Blaise](https://www.globalkeysolutions.net/people/yvesna-blaise/4cd6b7c2-78a7-490d-9354-52046bc7344f)

Company: https://www.globalkeysolutions.net/companies/sunrise-pharmaceutical-inc/3e90c0a2-44c0-46f7-a6ff-ee1377824088

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248