# FDA 483 - Kalitec Direct, LLC - March 04, 2020

Source: https://www.globalkeysolutions.net/records/483/kalitec-direct-llc/ad1d60ef-1d2f-4276-8c9f-f784461d69af

> FDA 483 for Kalitec Direct, LLC on March 04, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kalitec Direct, LLC
- Inspection Date: 2020-03-04
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Kalitec Direct, LLC, a medical device establishment in Oviedo, FL, identified two observations. The firm's procedures for purchasing controls were found inadequate, specifically concerning critical suppliers' process validation and personnel training. Additionally, the company's complaint handling procedures were deficient, as investigations did not consistently identify the most probable cause, particularly when user error was a potential factor.

## Related Officers

- [Principal ](https://www.globalkeysolutions.net/people/richard-k-vogel/3ddd8bff-24fd-40ee-b0a7-fb5333a520f5)

Company: https://www.globalkeysolutions.net/companies/kalitec-direct-llc/d5304629-c35e-4bf7-8663-704bf1297334

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