# FDA 483 - Smith & Nephew Wound Management - September 30, 2022

Source: https://www.keypedia.com/records/483/smith-nephew-wound-management/86877877-bd6f-4987-80fd-fb0b588300b0

> FDA 483 for Smith & Nephew Wound Management on September 30, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Smith & Nephew Wound Management
- Inspection Date: 2022-09-30
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Smith & Nephew, Inc. in Fort Worth, TX, a biological drug substance and drug product manufacturer, received a Form 483 with four observations. The inspection revealed failures in following stability study testing programs, inadequate written procedures for production and process controls, deficiencies in quality control unit procedures, and issues with facilities and equipment ensuring consistent process performance. These issues indicate significant concerns regarding product quality and manufacturing control.

## Related Documents

- [483 - 2021-07-20](https://www.keypedia.com/records/483/smith-nephew-wound-management/aba0eb13-a14c-4867-9fd4-811aa9d8ff1d)

## Related Officers

- [Laurimer Kuilan-Torres](https://www.keypedia.com/people/laurimer-kuilan-torres/a7f49e33-9d35-4dfe-8bcc-d369d3834ef4)
- [Lane V. Christensen](https://www.keypedia.com/people/lane-v-christensen/fb30085e-494e-460e-9f3d-c480902d6468)

Company: https://www.keypedia.com/companies/smith-nephew-wound-management/93a0c13a-73e3-4058-b819-d208e5fbdb5a

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd