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

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