# FDA 483 - EmCyte Corporation - November 15, 2023

Source: https://www.keypedia.com/records/483/emcyte-corporation/4c272d2c-fb39-43db-8948-25a030ea7725

> FDA 483 for EmCyte Corporation on November 15, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EmCyte Corporation
- Inspection Date: 2023-11-15
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: EmCyte Corporation in Fort Myers, FL, a manufacturer, received two observations during an FDA inspection. The firm was cited for inadequate documentation of corrective and preventive action activities, specifically regarding the verification of effectiveness without established acceptance criteria. Additionally, their complaint handling procedures lacked established time frames for processing complaints.

## Related Officers

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

Company: https://www.keypedia.com/companies/emcyte-corporation/90d260b6-b027-4087-9b16-f8a05bfef818

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