# FDA 483 - Trigen Laboratories - November 15, 2019

Source: https://www.globalkeysolutions.net/records/483/trigen-laboratories/a2675243-e065-4100-ba46-e3e0434a1add

> FDA 483 for Trigen Laboratories on November 15, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Trigen Laboratories
- Inspection Date: 2019-11-15
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Trigen Laboratories, Inc. in Tampa, FL, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm lacked adequate written procedures for handling customer complaints, managing Medical Device Reportable events, and controlling purchased products and services from suppliers. These issues indicate a failure to establish and maintain essential quality controls for medical device manufacturing.

## Related Officers

- [Joshua J. Silvestri](https://www.globalkeysolutions.net/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.globalkeysolutions.net/companies/trigen-laboratories/95cc9286-e0e2-418c-90e3-f01944b0fbe3

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6