# FDA 483 - Davion Inc - May 15, 2019

Source: https://www.globalkeysolutions.net/records/483/davion-inc/240cf694-e147-4b80-96b5-b89ae699bc2d

> FDA 483 for Davion Inc on May 15, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Davion Inc
- Inspection Date: 2019-05-15
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Davion Inc. in Newark, NJ, a contract manufacturer, was inspected and cited for significant quality system deficiencies. Observations included failures to follow quality control unit procedures, such as inadequate documentation for annual drug product reviews and change control, and not adhering to written cleaning and maintenance procedures for manufacturing equipment. Additionally, the firm lacked proper temperature and humidity monitoring in its warehouse for drug product storage.

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## Related Officers

- [Tonia F. Bernard](https://www.globalkeysolutions.net/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)

Company: https://www.globalkeysolutions.net/companies/davion-inc/2876e97d-f0e3-437f-b69f-db6c68c2e3ea

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