# FDA 483 - Wuxi Medical lnstrument Factory Co., Ltd. - November 15, 2024

Source: https://www.keypedia.com/records/483/wuxi-medical-lnstrument-factory-co-ltd/74c68d12-182b-46ab-89c1-7e9aed807166

> FDA 483 for Wuxi Medical lnstrument Factory Co., Ltd. on November 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wuxi Medical lnstrument Factory Co., Ltd.
- Inspection Date: 2024-11-15
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Wuxi Medical Instrument Factory Co., Ltd. in Wuxi, China, a sterile drug manufacturer, was cited with 10 observations during an FDA inspection. The observations highlight significant deficiencies across quality control, GMP training, sterile manufacturing processes, equipment maintenance, component testing, and stability programs, indicating a broad lack of adherence to CGMP requirements. The firm also failed to address previous FDA inspection observations.

## Related Documents

- [WARNING_LETTER - 2017-03-10](https://www.keypedia.com/records/warning_letter/wuxi-medical-lnstrument-factory-co-ltd/99d7f628-0a38-429b-b7d3-4d6b193f71a0)
- [WARNING_LETTER - 2024-11-15](https://www.keypedia.com/records/warning_letter/wuxi-medical-lnstrument-factory-co-ltd/7b101a2b-fa42-4be1-a593-d9e45862bebc)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)
- [Sara H. Gabel](https://www.keypedia.com/people/sara-h-gabel/cd0cd510-ef95-4322-a766-503c994c1f64)

Company: https://www.keypedia.com/companies/wuxi-medical-lnstrument-factory-co-ltd/b2bca31c-633b-4605-8d9d-7386ed467aab

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8