# FDA 483 - Summit Industries Inc. - September 30, 2022

Source: https://www.globalkeysolutions.net/records/483/summit-industries-inc/90dbd6f1-2303-459f-90fb-538b6464c597

> FDA 483 for Summit Industries Inc. on September 30, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Summit Industries Inc.
- Inspection Date: 2022-09-30
- Product Type: device
- Office Name: Chicago District Office
- Summary: Summit Industries Inc. in Miles, IL, a device manufacturer, received a Form 483 with four observations following an FDA inspection. The firm was cited for failing to submit timely malfunction reports to manufacturers, not promptly reviewing and investigating MDR-reportable complaints, and inadequately establishing procedures for incoming acceptance activities. These findings highlight deficiencies in the firm's quality system, particularly concerning post-market surveillance and complaint management.

## Related Documents

- [483 - 2025-03-20](https://www.globalkeysolutions.net/records/483/summit-industries-inc/6ba9082b-5cc3-4359-8bc0-99e74b392e5d)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)

Company: https://www.globalkeysolutions.net/companies/summit-industries-inc/f2e172b5-3734-481d-85d4-5258a68dd2be

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669