FDA Inspection 1304660 — Smith & Nephew Wound Management
The FDA completed an inspection of Smith & Nephew Wound Management on February 26, 2026 in Fort Worth, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 26, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fort Worth, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |