# FDA 483 - McPherson Enterprises, Inc., dba Implantable Devices - September 06, 2023

Source: https://www.keypedia.com/records/483/mcpherson-enterprises-inc-dba-implantable-devices/46bc965a-491c-43fa-b4aa-bf0a1964994a

> FDA 483 for McPherson Enterprises, Inc., dba Implantable Devices on September 06, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: McPherson Enterprises, Inc., dba Implantable Devices
- Inspection Date: 2023-09-06
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of McPherson Enterprises, Inc., dba Imp'lantable Devices in Pinellas Park, FL, revealed four significant deficiencies in their manufacturing processes for carotid shunt devices. These issues include a lack of established acceptance criteria for validation, inadequate risk analysis, insufficient supplier control procedures, and a failure to control environmental storage conditions. All observations were repeats from previous inspections, indicating persistent non-compliance.

## Related Documents

- [483 - 2021-10-29](https://www.keypedia.com/records/483/mcpherson-enterprises-inc-dba-implantable-devices/fb930b75-b5fd-4ab3-be91-4bb777afe0fd)
- [483 - 2023-09-06](https://www.keypedia.com/records/483/mcpherson-enterprises-inc-dba-implantable-devices/11d87237-78e6-4741-ad74-b59f04662bd3)

## Related Officers

- [Alex J. Wild](https://www.keypedia.com/people/alex-j-wild/bb1b66b3-19b9-480e-af0b-f06f8de0d930)

Company: https://www.keypedia.com/companies/mcpherson-enterprises-inc-dba-implantable-devices/c10c6e46-412d-460f-9c7c-a8b556a2207c

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