# FDA 483 - Shanghai SynTheAll Pharmaceutical Co., Ltd. - April 25, 2025

Source: https://www.keypedia.com/records/483/shanghai-syntheall-pharmaceutical-co-ltd/f070262e-ae7c-4e58-89a4-802656bdcde0

> FDA 483 for Shanghai SynTheAll Pharmaceutical Co., Ltd. on April 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shanghai SynTheAll Pharmaceutical Co., Ltd.
- Inspection Date: 2025-04-25
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Shanghai SynTheAll Pharmaceutical Co., Ltd., an API manufacturer in Shanghai, China, was cited for three observations during an FDA inspection. The firm failed to implement proper change controls and corrective actions for its electronic procedure system, lacked detailed and specific methods for collecting representative samples of materials, and performed environmental monitoring for airborne particulate matter under static instead of dynamic conditions in classified processing areas. These issues indicate deficiencies in quality control, sampling procedures, and environmental monitoring systems.

## Related Documents

- [483 - 2018-11-30](https://www.keypedia.com/records/483/shanghai-syntheall-pharmaceutical-co-ltd/417c14d3-4e42-45cc-b2e2-a47f5bc81ee7)

## Related Officers

- [Investigator](https://www.keypedia.com/people/marvin-d-jones/3101a8da-f5c1-4e0c-b4b1-b09be181be36)

Company: https://www.keypedia.com/companies/shanghai-syntheall-pharmaceutical-co-ltd/fa409b87-68e2-4a70-bda1-c33e8d807977

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8