# FDA WARNING_LETTER - Smith & Nephew, Inc. - November 26, 2013

Source: https://www.keypedia.com/records/warning_letter/smith-nephew-inc/4dc00cfe-5720-4322-b8b3-b3d366bc69ff

> FDA WARNING_LETTER for Smith & Nephew, Inc. on November 26, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Smith & Nephew, Inc.
- Inspection Date: 2013-11-26
- Product Type: Devices
- Office Name: Florida District Office
- Summary: On June 11, 2014, the FDA issued a Warning Letter to Smith & Nephew, Inc. following an inspection from November 12-26, 2013, at their Saint Petersburg, Florida facility, which manufactures Renasys Negative Pressure Wound Treatment (NPWT) devices. The inspection found these devices adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820).

Key violations include:
1.  **Failure to validate device design (21 CFR 820.30(g))**: Procedures did not ensure testing under actual/simulated use conditions, and risk-benefit assessments for identified hazards (e.g., exsanguination) were not performed.
2.  **Failure to control design changes (21 CFR 820.30(i))**: Procedures for verifying/validating design changes and evaluating their impact on risk assessments were not established/maintained. For example, a change to the Renasys Go Pump's leak alarm sensitivity was not properly evaluated.
3.  **Failure to implement corrective and preventive action (21 CFR 820.100(a))**: Complaint handling and post-market surveillance procedures lacked appropriate statistical methodology and effectiveness checks for corrective actions were not documented.
4.  **Failure to investigate

## Related Documents

- [WARNING_LETTER - 2015-03-26](https://www.keypedia.com/records/warning_letter/smith-nephew-inc/fe264f15-f981-4f49-ac72-4bedbb41d4ec)

## Related Officers

- [Elizabeth W. Ormond](https://www.keypedia.com/people/elizabeth-w-ormond/55f8bf5b-dbd6-4cd5-b3de-7606dec3727c)

Company: https://www.keypedia.com/companies/smith-nephew-inc/fc8c02e8-e978-443f-b02c-41a49b88ca49

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9