# FDA 483 - Tianjin Asymchem Pharmaceuticals Co., Ltd. - March 29, 2024

Source: https://www.keypedia.com/records/483/tianjin-asymchem-pharmaceuticals-co-ltd/fe66358f-6fad-4415-bd3c-11d9cbd3070f

> FDA 483 for Tianjin Asymchem Pharmaceuticals Co., Ltd. on March 29, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tianjin Asymchem Pharmaceuticals Co., Ltd.
- Inspection Date: 2024-03-29
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: An FDA inspection conducted from March 25-29, 2024, at Tianjin Asymchem Pharmaceuticals Co., Ltd. in Tianjin, P.R. China, resulted in the issuance of a Form FDA 483. The inspection highlighted significant deficiencies in the company's operational processes, particularly concerning personnel training and batch production record integrity, which are critical for adherence to Current Good Manufacturing Practices (CGMP).Key violations included inadequate personnel training procedures, where the firm's system lacked specific outlines for training modes and effectiveness evaluation. Review frequencies for standard operating procedures (SOPs) were vaguely defined, and training records for multiple employees were found to be incomplete, outdated, or missing essential revision details. Furthermore, certain personnel, including SOP approvers and quality assurance management, lacked documented training for critical procedures, indicating a gap in their foundational knowledge.Additionally, the inspection identified that batch production and control records were incomplete. Instructions within these records were deficient, often missing crucial information such as exact quantities for ingredients, target times for processes, or validated ranges for sampling and actions. Many entries were handwritten, raising concerns about data integrity and control.To address these observations, Tianjin Asymchem Pharmaceuticals Co., Ltd. is required to thoroughly investigate the root causes of these issues and implement comprehensive corrective and preventive actions. These actions should ensure that all personnel are properly trained, training records are accurately maintained, and batch production records are complete, clear, and adhere to established quality standards to achieve compliance with regulatory expectations.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/saied-a-asbagh/215bfa90-995f-4310-baf3-cd9d37639b7b)

Company: https://www.keypedia.com/companies/tianjin-asymchem-pharmaceuticals-co-ltd/1e469779-31a9-40d3-9bd8-d580e8489e7b

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