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

Source: https://www.globalkeysolutions.net/records/483/flextronics-electronics-technology-suzhou-co-ltd/8f9b915d-0447-4776-80aa-e0a9fdf67817

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

---

## 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: During an FDA inspection, Flextronics Electronics Technology (Suzhou) Co., Ltd., a foreign medical device contract manufacturer, received two observations. The firm was cited for inadequately established and implemented procedures for corrective and preventive actions, including insufficient root cause analysis and verification of effectiveness. Additionally, the company failed to adequately control nonconforming products, specifically by not extending investigations to all affected areas and lacking complete documentation for rework activities.

## 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/6bdbd56b-a52b-4db9-914d-e750ecf080a2)

## 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