# FDA 483 - Smith & Nephew Wound Management - July 20, 2021

Source: https://www.keypedia.com/records/483/smith-nephew-wound-management/aba0eb13-a14c-4867-9fd4-811aa9d8ff1d

> FDA 483 for Smith & Nephew Wound Management on July 20, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Smith & Nephew Wound Management
- Inspection Date: 2021-07-20
- 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 seven observations during an inspection from July 12-20, 2021. The observations primarily highlight significant deficiencies in aseptic processing, environmental controls, quality control unit oversight, and record-keeping practices for sterile drug products like (b) (4) ointment and gel. These issues indicate a lack of adherence to cGMP requirements, posing potential risks to product sterility and quality.

## Related Documents

- [483 - 2022-09-30](https://www.keypedia.com/records/483/smith-nephew-wound-management/86877877-bd6f-4987-80fd-fb0b588300b0)

## Related Officers

- [investigator](https://www.keypedia.com/people/eric-dong/762c3fe2-593d-41b6-8903-7c354f732435)

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