# FDA 483 - General Devices Llc - June 11, 2015

Source: https://www.globalkeysolutions.net/records/483/general-devices-llc/2e175c99-1fb0-4a00-b4f0-d05d5bc60537

> FDA 483 for General Devices Llc on June 11, 2015. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: General Devices Llc
- Inspection Date: 2015-06-11
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of 86 Harriet Ave Corporation DBA General Devices, a medical device manufacturer in Ridgefield, NJ, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventative actions, medical device reporting, and design changes. These issues indicate a lack of robust controls over product quality and safety.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/li-lu/fa120f19-beac-4d2d-8059-339a93911b85)

Company: https://www.globalkeysolutions.net/companies/general-devices-llc/2ab2cc56-b870-4fc9-9a3f-f8bd76bc5cea

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248