# FDA 483 - ChemWerth Pharmaceutical Technology (Shanghai) Co., LTD - April 01, 2024

Source: https://www.globalkeysolutions.net/records/483/chemwerth-pharmaceutical-technology-shanghai-co-ltd/a3be8755-61cd-4c79-9a64-45adc3798a85

> FDA 483 for ChemWerth Pharmaceutical Technology (Shanghai) Co., LTD on April 01, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ChemWerth Pharmaceutical Technology (Shanghai) Co., LTD
- Inspection Date: 2024-04-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: ChemWerth Pharmaceutical Technology (Shanghai) Co., LTD, a contract testing laboratory, was inspected by the FDA from April 1-3, 2024. The inspection revealed a significant issue regarding the calibration and qualification of instruments used for particle size distribution analysis. Specifically, the firm failed to re-qualify a Malvern Mastersizer 3000 and did not qualify a stand-alone sonicator, indicating a lack of adherence to established programs for instrument control.

## Related Officers

- [David D. Anderson](https://www.globalkeysolutions.net/people/david-d-anderson/c099420c-c58b-4136-b633-90ffc3e9cd81)
- [Wayne D. Mcgrath](https://www.globalkeysolutions.net/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.globalkeysolutions.net/companies/chemwerth-pharmaceutical-technology-shanghai-co-ltd/bdd0edbf-bcaf-451b-ba0a-84c241db8655

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