FDA WARNING_LETTER - Electric Mobility Corp - November 16, 2010

On October 19, 2010, the FDA inspected Electric Mobility Corporation in Sewell, New Jersey, and found that their electric scooters and powered wheelchairs were adulterated and misbranded. The inspection revealed non-conformity with the Quality System (QS) regulation (21 CFR Part 820) and Medical Device Reporting (MDR) regulation (21 CFR Part 803).

Key violations include: 1. **Design Validation (21 CFR 820.30(g)):** Failure to validate device design, specifically for We Go 250 power chairs, to ensure specifications met user needs. The firm's response was inadequate as no documentation of corrected design validation was provided. 2. **Design Change Control (21 CFR 820.30(i)):** Inadequate procedures for identifying, documenting, validating, and approving design changes. Examples include changes to the We Go power chair (patient transfer lock) and scooter controller software without proper validation/verification. The firm's response was inadequate, lacking evidence of considering the observation for other design changes. 3. **Complaint Investigation (21 CFR 820.198(c)):** Repeated failure to review, evaluate, and investigate complaints involving device failure, labeling, or packaging. Several specific complaints (e.g., scooter cutting out, surging, seat problems) lacked documented investigations. The firm'