# FDA 483 - American Medical Endoscopy, Inc. - October 11, 2023

Source: https://www.keypedia.com/records/483/american-medical-endoscopy-inc/74f01cf9-7d54-4f14-86cf-7095f6fad9e4

> FDA 483 for American Medical Endoscopy, Inc. on October 11, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Medical Endoscopy, Inc.
- Inspection Date: 2023-10-11
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of American Medical Endoscopy, Inc., a relabeler in Doral, FL, identified a significant procedural deficiency. The firm was cited for not having developed written Medical Device Reporting (MDR) procedures. This includes the absence of established guidelines for timeframes and necessary forms when the firm becomes aware of an MDR reportable event.

## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.keypedia.com/companies/american-medical-endoscopy-inc/a0f3c9e8-eb28-4495-94fb-37f7723ff988

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