# FDA 483 - Surgical Instrument Manufacturers, LLC - February 22, 2024

Source: https://www.keypedia.com/records/483/surgical-instrument-manufacturers-llc/3f907135-81a8-4c54-a839-d3547dd753bb

> FDA 483 for Surgical Instrument Manufacturers, LLC on February 22, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Surgical Instrument Manufacturers, LLC
- Inspection Date: 2024-02-22
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Surgical Instrument Manufacturers, LLC in Fenton, MO, was cited during an FDA inspection from February 20-22, 2024, for significant deficiencies in its corrective and preventive action (CAPA) procedures. The firm failed to adequately establish and document CAPA processes, specifically regarding root cause determination, verification of effectiveness, and implementation records for actions taken in response to complaints of mislabeled medical devices.

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.keypedia.com/companies/surgical-instrument-manufacturers-llc/3a124509-bd32-4dd4-80ec-fe770e81a142

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8