# FDA 483 - Wuxi STA Pharmaceutical Co., Ltd - March 03, 2023

Source: https://www.keypedia.com/records/483/wuxi-sta-pharmaceutical-co-ltd/0cb46d3e-9f9a-4561-ae15-b80b7e6556da

> FDA 483 for Wuxi STA Pharmaceutical Co., Ltd on March 03, 2023. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wuxi STA Pharmaceutical Co., Ltd
- Inspection Date: 2023-03-03
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: This FDA Form 483 document details observations made during an inspection of a pharmaceutical manufacturing facility. The inspection revealed several deficiencies related to the firm's quality system and manufacturing processes for sterile drug products.

Observation 1 indicates the firm failed to establish an adequate system for monitoring environmental conditions within the aseptic processing area. This suggests a potential risk to product sterility and a lack of control over critical manufacturing environments.

Observation 2 notes that the sterilization process for equipment used in the production of sterile drug products was not adequately validated. This is a critical finding as it directly impacts the sterility assurance of the final product.

Observation 3 highlights that the firm did not conduct thorough investigations into discrepancies and failures found in batch production records. This indicates a weakness in their corrective and preventive action (CAPA) system and an inability to identify root causes of issues.

Finally, Observation 4 states that the firm did not maintain proper documentation for the training of personnel involved in the manufacturing process. This suggests a lack of control over personnel competency and adherence to good manufacturing practices (GMP).

These observations collectively point to significant issues within the firm's quality management system, particularly concerning sterile manufacturing controls, process validation, deviation management, and personnel training. Addressing these deficiencies is crucial for ensuring product quality, safety, and regulatory compliance.

## Related Documents

- [483 - 2023-03-03](https://www.keypedia.com/records/483/wuxi-sta-pharmaceutical-co-ltd/ada6e1b2-a1f6-4eff-b151-0d16cc88a7a8)

## Related Officers

- [Tonia F. Bernard](https://www.keypedia.com/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)

Company: https://www.keypedia.com/companies/wuxi-sta-pharmaceutical-co-ltd/892c7730-c0f9-4b49-9c80-f65ee1e21b57

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-quality-operations/6b0153a9-c1d1-46a5-8b10-836d2ae44ffe