# FDA 483 - Solaris Pharma Corp - October 31, 2019

Source: https://www.keypedia.com/records/483/solaris-pharma-corp/e583753a-c336-463d-90cf-63c98c7a3038

> FDA 483 for Solaris Pharma Corp on October 31, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Solaris Pharma Corp
- Inspection Date: 2019-10-31
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Sol-Gel Technologies Ltd. in Bridgewater, NJ, was inspected and cited for significant deficiencies in data integrity, deviation management, and equipment cleaning and maintenance. The firm lacked proper controls over computer systems, failed to investigate and document deviations from procedures, and did not maintain or clean laboratory equipment adequately. These issues indicate a lack of robust quality control and data integrity practices.

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## Related Officers

- [Logman A Mohamed](https://www.keypedia.com/people/logman-a-mohamed/9c1dc6f7-1ded-4dfb-b7e6-79a58547e6c6)
- [Vvesna C Blaise](https://www.keypedia.com/people/vvesna-c-blaise/fe5a2321-1072-48f1-ba45-7afda6352a0a)

Company: https://www.keypedia.com/companies/solaris-pharma-corp/2730f83a-223f-4ef6-95e1-4e3b069342ce

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