# FDA 483 - Bushu Pharmaceuticals Ltd. - December 02, 2022

Source: https://www.keypedia.com/records/483/bushu-pharmaceuticals-ltd/47c2fcd8-6261-4cbd-a7fb-ee65aeee4c88

> FDA 483 for Bushu Pharmaceuticals Ltd. on December 02, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bushu Pharmaceuticals Ltd.
- Inspection Date: 2022-12-02
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 document details observations from an inspection, highlighting deficiencies in quality control and facility management.

**Observation 1** addresses the quality control unit's responsibilities and procedures not being fully written or followed. Specifically:
*   Complaint records for on-site investigations (Procedure 141.0-QA) are incomplete, lacking full documentation or justification for reported actions. Evaluation of retention samples is not fully described (e.g., quantity, inspection steps, timeliness). Complaints citing "Lack of Efficacy" (e.g., "b) <4) -l Tabs~~ mg CHK2003-004 /2003-005") only included visual inspection, not analytical testing.
*   Deviation reports (Procedure 1B7.0QA) are not always fully documented to support conclusions or "no further actions." For instance, Deviation report DVK210238 (16Dec2021) for failed disintegration tests in "b) <4) mg Lot fbl < )7 and fbl < )7" (results NMTl min) resulted in no additional actions after an evaluation, and both lots were released.

**Observation 3** identifies deficiencies in separate or defined areas and control systems to prevent contamination or mix-ups. Specifically:
*   Records of abnormal events in Manufacturing Building [redacted] (SOP 411

## Related Documents

- [483 - 2022-12-02](https://www.keypedia.com/records/483/bushu-pharmaceuticals-ltd/b6765841-7334-4c55-a03f-48209c769b8e)

## Related Officers

- [Investigator](https://www.keypedia.com/people/noreen-muniz/0bb20d12-62ad-42aa-8b0a-c44b339d413f)

Company: https://www.keypedia.com/companies/bushu-pharmaceuticals-ltd/f3ccab51-b6fa-4873-b2de-61ba32d7967e

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c