# FDA 483 - Pharmaron (Ningbo) Technology Development Co., Ltd. - November 01, 2024

Source: https://www.globalkeysolutions.net/records/483/pharmaron-ningbo-technology-development-co-ltd/92c2bad6-54a1-4f55-84db-c117e97228fa

> FDA 483 for Pharmaron (Ningbo) Technology Development Co., Ltd. on November 01, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaron (Ningbo) Technology Development Co., Ltd.
- Inspection Date: 2024-11-01
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Pharmeron (Ningbo) Technology Development Co. Ltd., an API manufacturer in Ningbo, China, revealed significant deficiencies in quality control. Observations included a lack of growth promotion testing for microbiological media, inadequate environmental monitoring in processing areas, and insufficient written procedures for raw material sampling. These issues indicate a failure to ensure drug product quality and compliance with manufacturing standards.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/pharmaron-ningbo-technology-development-co-ltd/c40334bd-b474-48eb-91c6-51a228da2a42

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