# FDA 483 - Electroskip, Llc - June 07, 2022

Source: https://www.globalkeysolutions.net/records/483/electroskip-llc/7eb62704-f79d-4296-84e4-cacce01848d1

> FDA 483 for Electroskip, Llc on June 07, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Electroskip, Llc
- Inspection Date: 2022-06-07
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Electroskip, Llc, a medical device manufacturer in Buffalo, NY, was inspected by the FDA from June 1-7, 2022. The inspection revealed significant deficiencies across multiple quality system areas, particularly concerning design controls, corrective and preventive actions, complaint handling, and document control. The firm lacked adequately established procedures and documentation for critical processes related to its eskipitrainer device.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/electroskip-llc/c5690972-ffba-4b4f-8982-e4c766097411

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