# FDA 483 - WISE PLASTICS TECHNOLOGIES INC - May 19, 2023

Source: https://www.globalkeysolutions.net/records/483/wise-plastics-technologies-inc/6c4af411-bac1-485d-bbf8-8091fbe3df7c

> FDA 483 for WISE PLASTICS TECHNOLOGIES INC on May 19, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: WISE PLASTICS TECHNOLOGIES INC
- Inspection Date: 2023-05-19
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of WISE PLASTICS TECHNOLOGIES INC in West Chicago, IL, a contract manufacturer of medical devices, revealed significant deficiencies in their quality management system. Observations included inadequate corrective and preventive action procedures, insufficient software validation for their quality system, and a quality plan that fails to reference relevant FDA regulations like 21 CFR 820. These issues indicate a lack of robust controls for managing product quality and regulatory compliance.

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.globalkeysolutions.net/companies/wise-plastics-technologies-inc/d053c306-72dd-4c6a-b5c2-74988aadaf0d

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