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

Source: https://www.keypedia.com/records/483/changzhou-pharmaceutical-factory/057716c4-f8bd-4678-b484-fac3f0c2385f

> 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: Baltimore District Office
- Summary: During an inspection conducted from approximately January 8-12, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Changzhou Pharmaceutical Factory Company Ltd., detailing significant Current Good Manufacturing Practice (cGMP) deficiencies. The observations primarily focused on inadequate equipment cleaning and maintenance across both drug product and Active Pharmaceutical Ingredient (API) manufacturing. For drug products, investigators found dirty tablet press equipment with powder and debris despite documented cleaning, and the firm lacked validated cleaning procedures specifying the maximum number of batches before comprehensive cleaning. This was particularly concerning for shared equipment previously linked to customer complaints of product contamination. Furthermore, the FDA noted failures in the company's quality system regarding deviation management and customer complaint handling. The firm did not thoroughly investigate or report critical product issues, such as brittle capsule shells leading to broken capsules shipped to the U.S. market, or numerous unsealed drug product bottles reported by customers. Deviations were improperly classified, leading to non-reporting of serious quality issues to the FDA within required timelines. Additionally, reserve samples were not visually inspected for seal integrity, despite prior complaints about unsealed products. In API manufacturing, equipment in multiple blocks exhibited extensive rust and residue build-up, indicating insufficient cleaning and maintenance. Crucially, maintenance activities were conducted outside the established Quality System and without proper change control, posing substantial risks of contamination. Changzhou Pharmaceutical Factory Company Ltd. is required to provide a comprehensive response to these observations, outlining specific corrective and preventive actions to address all identified cGMP violations and ensure future compliance.

## Related Documents

- [483 - 2024-01-12](https://www.keypedia.com/records/483/changzhou-pharmaceutical-factory/c3102851-47fa-42ab-8972-935f1ca05038)
- [483 - 2024-01-12](https://www.keypedia.com/records/483/changzhou-pharmaceutical-factory/cd894f30-d17f-4d2d-b9f2-85a72e934cea)

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

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa