# FDA 483 - Tools For Surgery, LLC - November 06, 2025

Source: https://www.keypedia.com/records/483/tools-for-surgery-llc/7a8c7dc2-7c2b-4a65-8591-71c437b19b6b

> FDA 483 for Tools For Surgery, LLC on November 06, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tools For Surgery, LLC
- Inspection Date: 2025-11-06
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Tools For Surgery, LLC in Stony Brook, NY on November 6, 2025, revealed one observation. The firm failed to provide required information for their ZZIRÉN® OROGASTRIC TUBE to the Global Unique Device Identification Database. This indicates a lapse in regulatory compliance for medical device identification.

## Related Officers

- [Preston M. Lee](https://www.keypedia.com/people/preston-m-lee/e44adac3-a915-4bfb-8b06-a41ea5803358)

Company: https://www.keypedia.com/companies/tools-for-surgery-llc/5d4c047f-6263-4804-97eb-738c67bec539

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961