# FDA 483 - Threshold NeuroDiagnostics Llc - September 14, 2021

Source: https://www.keypedia.com/records/483/threshold-neurodiagnostics-llc/5a88380d-7df7-444b-9cac-80b67f5ddf29

> FDA 483 for Threshold NeuroDiagnostics Llc on September 14, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Threshold NeuroDiagnostics Llc
- Inspection Date: 2021-09-14
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Threshold Neurodiagnostics Llc in Minoa, NY, a medical device specification developer and labeler, was inspected by the FDA and received a Form 483. The inspection revealed a pervasive lack of established procedures and documentation across nearly all aspects of its quality system, including design controls, device master records, purchasing, quality audits, equipment calibration, corrective and preventive actions, complaint handling, and nonconforming product control. These findings indicate significant deficiencies in the firm's adherence to medical device quality system regulations.

## Related Officers

- [Matthew D. Schnittker](https://www.keypedia.com/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.keypedia.com/companies/threshold-neurodiagnostics-llc/674e6170-9ef9-4adf-a2f4-15bac1914b57

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961