# FDA 483 - Slater Endoscopy, LLC - February 02, 2023

Source: https://www.globalkeysolutions.net/records/483/slater-endoscopy-llc/5a508b1e-f87c-4f42-ae17-0ae627f77172

> FDA 483 for Slater Endoscopy, LLC on February 02, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Slater Endoscopy, LLC
- Inspection Date: 2023-02-02
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Slater Endoscopy, LLC, a medical device manufacturer in Miramar, FL, was inspected by the FDA from January 31 to February 2, 2023. The inspection revealed a deficiency in document control procedures, specifically regarding the updating of Design History Files and Device Master Records after material and process changes. This indicates a moderate compliance issue related to quality system documentation.

## Related Documents

- [483 - 2025-09-26](https://www.globalkeysolutions.net/records/483/slater-endoscopy-llc/6d0d353c-e228-495f-8366-0ec3410ed08b)

## Related Officers

- [Dianiris C. Ayala](https://www.globalkeysolutions.net/people/dianiris-c-ayala/ba6c5538-201b-4c9a-8f23-e160db6868e6)

Company: https://www.globalkeysolutions.net/companies/slater-endoscopy-llc/c044e678-bce1-4046-bc56-2fb333ddcb28

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