# FDA 483 - Flextronics International USA, Inc - April 19, 2022

Source: https://www.keypedia.com/records/483/flextronics-international-usa-inc/fc14dbea-6d47-409f-843e-94c5287a97a4

> FDA 483 for Flextronics International USA, Inc on April 19, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Flextronics International USA, Inc
- Inspection Date: 2022-04-19
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Flextronics International USA, Inc. in Buffalo Grove, IL, a contract medical device manufacturer, revealed significant deficiencies in its quality system. The firm failed to adequately review and investigate MDR-reportable complaints, maintain proper documentation for corrective and preventive actions, and ensure personnel training was properly documented. These issues indicate a lack of robust quality control over critical manufacturing and post-market surveillance processes.

## Related Officers

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

Company: https://www.keypedia.com/companies/flextronics-international-usa-inc/65c4ff52-aea4-409c-80f5-0972a80fa54d

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