# SurGenTec, LLC – FDA Inspection, Apr 18, 2019

Source: https://www.keypedia.com/records/fda_inspections/surgentec-llc/b3556f6f-c5c7-4fbb-bec0-7625d7822496
Source feed: FDA_Inspections

> FDA inspection 1086833 of SurGenTec, LLC, April 18, 2019. Classification: Voluntary Action Indicated (VAI). 3 citations under 21 CFR parts 803 and 820. Form 483 issued. 3 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1086833
- Company Name: SurGenTec, LLC
- Inspection Date: 2019-04-18
- Classification: Voluntary Action Indicated (VAI)
- Classification Code: VAI
- Project Area: Compliance: Devices
- Product Type: Devices
- Center: Medical Devices & Rad Health
- Office Name: Center for Devices and Radiological Health
- Citation Count: 3

## Related Documents

- FDA Inspection 1194136 - 2022-12-14
- FDA Inspection 1192878 - 2022-12-14
- FDA Inspection 1069659 - 2018-10-11

## Related Officers

- [Investigator](https://www.keypedia.com/people/david-m-wilkinson/5e81ba03-7602-46d6-b675-26efc77d28db)
- [Joshua J. Silvestri](https://www.keypedia.com/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.keypedia.com/companies/surgentec-llc/75555d07-66bb-43c4-9fc8-e3dc25aac38a

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7