# FDA 483 - Shandong New Time Pharmaceutical Co. Ltd. - July 01, 2024

Source: https://www.globalkeysolutions.net/records/483/shandong-new-time-pharmaceutical-co-ltd/74710a97-7da7-4a05-9544-dfcc9791cb9e

> FDA 483 for Shandong New Time Pharmaceutical Co. Ltd. on July 01, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shandong New Time Pharmaceutical Co. Ltd.
- Inspection Date: 2024-07-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Shandong New Time Pharmaceutical Co., Ltd. in Linyi, China, identified critical deficiencies in aseptic processing for sterile drug products and inadequate monitoring and validation of manufacturing processes. These issues include failures in RABS operation, aseptic transfer techniques, environmental monitoring, and the establishment of process parameters, indicating a high risk of product contamination and variability. The findings suggest a significant lack of control over critical manufacturing steps.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

Company: https://www.globalkeysolutions.net/companies/shandong-new-time-pharmaceutical-co-ltd/470fe860-121a-4594-b9a5-e6bf05ce1926

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