# FDA WARNING_LETTER - Flextronics Electronics Technology (Suzhou) Co., Ltd. - October 16, 2014

Source: https://www.keypedia.com/records/warning_letter/flextronics-electronics-technology-suzhou-co-ltd/1a1d138c-7958-4f59-bfeb-eb32a4b756e9

> FDA WARNING_LETTER for Flextronics Electronics Technology (Suzhou) Co., Ltd. on October 16, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Flextronics Electronics Technology (Suzhou) Co., Ltd.
- Inspection Date: 2014-10-16
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On February 19, 2015, the FDA issued a Warning Letter to Flextronics International, Ltd. following an inspection of their Suzhou, China facility from October 13-16, 2014. The inspection revealed that the firm's patient arrhythmia monitors are adulterated under 21 U.S.C. § 351(h) because their manufacturing processes do not conform to the Quality System regulation (21 CFR Part 820).

Key violations include:
1. **Failure to validate processes (21 CFR 820.75(a)):** The firm did not perform Process Qualification for a new machine, and Installation/Operational Qualification reports lacked adequate documentation, including equipment identification, calibration status, and recorded data.
2. **Inadequate sampling methods (21 CFR 820.250(b)):** Sampling plans for incoming components and process validation lacked sufficient requirements for unit numbers and valid statistical rationale.
3. **Deficient complaint handling (21 CFR 820.198(a)):** Complaint files lacked required information such as complainant details, investigation dates/results, and documented corrective actions.
4. **Inadequate Corrective and Preventive Action (CAPA) procedures (21 CFR 820.100(a)):** CAPA activities lacked adequate documentation of investigations, implementation of corrective actions, and validation

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- [483 - 2018-11-05](https://www.keypedia.com/records/483/flextronics-electronics-technology-suzhou-co-ltd/6bdbd56b-a52b-4db9-914d-e750ecf080a2)
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## Related Officers

- [Jan B. Welch](https://www.keypedia.com/people/jan-b-welch/65bfaf7c-7ce6-4c33-80bd-090efbf2eec5)

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

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7