# FDA 483 - Legend Aerospace, Inc. - May 27, 2022

Source: https://www.keypedia.com/records/483/legend-aerospace-inc/0456fe91-880d-4355-8504-869d5c1f89be

> FDA 483 for Legend Aerospace, Inc. on May 27, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Legend Aerospace, Inc.
- Inspection Date: 2022-05-27
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Legend Aerospace, Inc. in Medley, FL, a manufacturer and repackager/relabeler of medical devices, was inspected and cited for six observations related to its quality system. The firm failed to establish adequate procedures for complaint handling, Medical Device Reporting (MDR), corrective and preventive actions, servicing activities, control of nonconforming product, and supplier management. Several observations were repeats from a previous inspection in 2017, indicating persistent quality system deficiencies.

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Company: https://www.keypedia.com/companies/legend-aerospace-inc/5979c366-2166-4518-aef4-4a832fb1b30d

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