# FDA 483 - Flextronics Electronics Technology (Suzhou) Co., Ltd. - November 05, 2018

Source: https://www.globalkeysolutions.net/records/483/flextronics-electronics-technology-suzhou-co-ltd/6bdbd56b-a52b-4db9-914d-e750ecf080a2

> FDA 483 for Flextronics Electronics Technology (Suzhou) Co., Ltd. on November 05, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Flextronics Electronics Technology (Suzhou) Co., Ltd.
- Inspection Date: 2018-11-05
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Flextronics Electronics Technology (Suzhou) Co., Ltd., a foreign medical device contract manufacturer, was inspected by the FDA from November 5-8, 2018. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding corrective and preventive actions and the control of nonconforming products. These issues indicate a lack of adequately established and implemented procedures for ensuring product quality and preventing recurrence of problems.

## Related Documents

- [WARNING_LETTER - 2014-10-16](https://www.globalkeysolutions.net/records/warning_letter/flextronics-electronics-technology-suzhou-co-ltd/1a1d138c-7958-4f59-bfeb-eb32a4b756e9)
- [483 - 2018-11-05](https://www.globalkeysolutions.net/records/483/flextronics-electronics-technology-suzhou-co-ltd/d76de8a0-26b7-42f6-8bfe-3b5f176cefd1)
- [483 - 2018-11-05](https://www.globalkeysolutions.net/records/483/flextronics-electronics-technology-suzhou-co-ltd/8f9b915d-0447-4776-80aa-e0a9fdf67817)

## Related Officers

- [Dianiris C. Ayala](https://www.globalkeysolutions.net/people/dianiris-c-ayala/ba6c5538-201b-4c9a-8f23-e160db6868e6)

Company: https://www.globalkeysolutions.net/companies/flextronics-electronics-technology-suzhou-co-ltd/70a7d07b-37e4-44e2-a483-dc8b504ba9ed

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd