# FDA WARNING_LETTER - Smith & Nephew, Inc. - March 26, 2015

Source: https://www.keypedia.com/records/warning_letter/smith-nephew-inc/fe264f15-f981-4f49-ac72-4bedbb41d4ec

> FDA WARNING_LETTER for Smith & Nephew, Inc. on March 26, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Smith & Nephew, Inc.
- Inspection Date: 2015-03-26
- Product Type: Devices
- Office Name: New England District Office
- Summary: The FDA issued a Warning Letter to Smith & Nephew, Inc. following an inspection from March 4-26, 2015, at their Andover, MA facility. The firm, a specification developer for arthroscopy and gynecology devices including TRUCLEAR ULTRA Reciprocating Morcellators, was found to have adulterated devices due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Significant violations include:
1.  **Failure to verify/validate CAPA effectiveness (21 CFR 820.100(a)(4)):** Eight corrective action reports lacked sufficient verification of effectiveness. For example, CAR 12-0014 for TRUCLEAR ULTRA Morcellators, addressing undersized sluff chambers and loss of visualization, was closed without effectiveness verification, and complaints persisted. Reworked lots were released before a Health Hazard Assessment was finalized, contrary to internal procedures. Other CAPAs (MMP 13-0003, MMP 13-0004, A13-0006) remained open with unverified corrections. The firm placed a hold on TRUCLEAR Ultra Reciprocating Morcellators 4.0 shipments and is conducting a new Health Risk Assessment. Systemic CAPA improvements are planned, with effectiveness verification by January 2016.
2.  **Failure to control non-con

## Related Documents

- [WARNING_LETTER - 2013-11-26](https://www.keypedia.com/records/warning_letter/smith-nephew-inc/4dc00cfe-5720-4322-b8b3-b3d366bc69ff)

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/joseph-s-matrisciano/62ff5cd6-c3ab-4443-bf26-f61a512f3960)
- [chief executive officer](https://www.keypedia.com/people/oliver-bohuon/d2898fa1-5c06-467f-8f63-2c7657eaf537)

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

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144