# FDA 483 - Smith & Nephew Wound Management - February 26, 2026

Source: https://www.keypedia.com/records/483/smith-nephew-wound-management/e68be253-b643-47fe-b768-810964014c49

> FDA 483 for Smith & Nephew Wound Management on February 26, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Smith & Nephew Wound Management
- Inspection Date: 2026-02-26
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Smith & Nephew Wound Management in Fort Worth, TX, a drug substance and biotech sterile drug manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate investigations into out-of-specification results and adverse events, ineffective corrective actions, and a failure to properly manage and test critical components, leading to sterility failures. These issues highlight serious concerns regarding product quality and patient safety.

## Related Documents

- [483 - 2021-07-20](https://www.keypedia.com/records/483/smith-nephew-wound-management/aba0eb13-a14c-4867-9fd4-811aa9d8ff1d)
- [483 - 2022-09-30](https://www.keypedia.com/records/483/smith-nephew-wound-management/86877877-bd6f-4987-80fd-fb0b588300b0)
- [483 - 2026-02-26](https://www.keypedia.com/records/483/smith-nephew-wound-management/a98ab89a-c608-4cf3-8b9e-d568591e8d83)

## Related Officers

- [Cecilia H. Kieu](https://www.keypedia.com/people/cecilia-h-kieu/3ba5feb0-d49e-4301-ae5c-b84bd604a159)
- [issuing_officer](https://www.keypedia.com/people/gavin-t-cua/6f498dd6-2c4b-42e9-8ddc-3c2a7c97afef)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab