# FDA 483 - Porton Pharma Solutions Ltd - November 19, 2018

Source: https://www.globalkeysolutions.net/records/483/porton-pharma-solutions-ltd/adfbb16d-15b8-4941-bd2c-92b15d662f69

> FDA 483 for Porton Pharma Solutions Ltd on November 19, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Porton Pharma Solutions Ltd
- Inspection Date: 2018-11-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Porton Pharma Solutions Ltd., an API manufacturer in Changshou, China, was cited for significant deficiencies in its quality control unit, laboratory oversight, and data integrity practices. Observations included incomplete and non-contemporaneous cGMP training records, a lack of an adequate data integrity program for electronic laboratory systems, and insufficient investigation and documentation of unexplained discrepancies in analytical testing. These issues indicate a systemic failure to ensure data reliability and adherence to quality control procedures.

## Related Officers

- [Arsen Karapetyan](https://www.globalkeysolutions.net/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.globalkeysolutions.net/companies/porton-pharma-solutions-ltd/79b53452-47cf-4b03-a8a7-fae3ed70635b

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1