# FDA 483 - One Surgical Inc. - October 21, 2021

Source: https://www.keypedia.com/records/483/one-surgical-inc/acb50f59-4613-408e-8f29-78494f1cd61e

> FDA 483 for One Surgical Inc. on October 21, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: One Surgical Inc.
- Inspection Date: 2021-10-21
- Product Type: other
- Office Name: New Orleans District Office
- Summary: One Surgical, Inc., a repacker/relabeler in Memphis, TN, received a Form FDA 483 with two observations during an inspection. The firm failed to adequately document corrective and preventive action activities, specifically investigations, root causes, and plan execution. Additionally, complaint files were not properly maintained, with several closed complaints lacking documentation of investigations.

## Related Officers

- [Javelle P. Spann](https://www.keypedia.com/people/javelle-p-spann/31a8f7a8-e442-4f5a-b33f-55bfe911e61b)

Company: https://www.keypedia.com/companies/one-surgical-inc/702df3d9-fa74-482e-82c2-fb61e14384be

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea