# FDA 483 - Schoelly USA Inc - December 01, 2021

Source: https://www.keypedia.com/records/483/schoelly-usa-inc/0f4fbf04-6a96-45fa-8b4d-d3fb9f451601

> FDA 483 for Schoelly USA Inc on December 01, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Schoelly USA Inc
- Inspection Date: 2021-12-01
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Schoelly USA Inc. in Northborough, MA, identified one observation related to inadequate environmental control procedures. Specifically, the firm lacked established procedures for controlling electrostatic discharge (ESD) or electrical overstress (EOS) regarding the testing, approval, and use of a screwdriver at a designated ESD station. This indicates a moderate severity issue concerning quality system requirements for device manufacturing.

## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/schoelly-usa-inc/09349be2-0d24-4230-aee6-acb0c8388924

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94