# FDA 483 - Polyconversions, Inc. - August 07, 2019

Source: https://www.globalkeysolutions.net/records/483/polyconversions-inc/ab9984fe-c019-4f3c-9c21-cf7cd8a43d84

> FDA 483 for Polyconversions, Inc. on August 07, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Polyconversions, Inc.
- Inspection Date: 2019-08-07
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Polyconversions, Inc. in Champaign, IL, revealed significant deficiencies in the firm's quality system for manufacturing PolyWear Embossed Gowns. The inspection cited failures to establish and maintain critical procedures for medical device reporting, corrective and preventive actions, process validation, incoming product acceptance, complaint handling, and supplier quality. These issues indicate a lack of adequate controls to ensure device safety and quality.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/polyconversions-inc/7db62b41-d472-43e8-b755-41f6875099b1

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