# FDA 483 - TeleMed Systems - July 02, 2026

Source: https://www.keypedia.com/records/483/telemed-systems/a8ca302e-0005-4580-9bca-dfd144fb110e

> FDA 483 for TeleMed Systems on July 02, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TeleMed Systems
- Inspection Date: 2026-07-02
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of Shent USA, Inc. in Northborough, MA, a medical device manufacturer, revealed significant deficiencies in design and development outputs. The firm failed to adequately define material specifications for its Class II Sclerotherapy Needle and its sterile barrier system packaging. These issues indicate a lack of robust design control and potential risks to product quality.

## Related Officers

- [Power Trader/Data Scientist](https://www.keypedia.com/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

Company: https://www.keypedia.com/companies/telemed-systems/e7ec5771-eeb5-49af-8c28-ed2821cfbc11

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