# FDA 483 - Changzhou Pharmaceutical Factory - January 12, 2024

Source: https://www.keypedia.com/records/483/changzhou-pharmaceutical-factory/cd894f30-d17f-4d2d-b9f2-85a72e934cea

> FDA 483 for Changzhou Pharmaceutical Factory on January 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Changzhou Pharmaceutical Factory
- Inspection Date: 2024-01-12
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Changzhou Pharmaceutical Factory Company Ltd. was inspected and cited for multiple significant deficiencies in its drug and API manufacturing operations. Observations included inadequate equipment cleaning and maintenance procedures, failure to thoroughly investigate discrepancies and report critical deviations, and insufficient visual examination of reserve samples for seal integrity. These issues indicate a lack of robust quality control and adherence to established procedures, potentially impacting product quality and safety.

## Related Documents

- [483 - 2024-01-12](https://www.keypedia.com/records/483/changzhou-pharmaceutical-factory/c3102851-47fa-42ab-8972-935f1ca05038)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)
- [Investigator](https://www.keypedia.com/people/amy-n-chen/c3515e0e-dbb9-4540-bd2b-82c06d00dd42)

Company: https://www.keypedia.com/companies/changzhou-pharmaceutical-factory/eea165e1-3df2-47c8-94b9-e8400af46bc4

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3