FDA WARNING_LETTER - Mega Electronics Ltd. - August 29, 2013

On August 26-29, 2013, an FDA inspection of Mega Electronics Ltd. in Kuopio, Finland, revealed that their FemiScan Home Trainer Incontinence Device and ME6000 Biomonitor Device are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820). The firm's September 10, 2013, response to the FDA 483 was deemed inadequate.

Violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: The CAPA procedure lacks requirements for analyzing quality data to identify nonconforming products or quality problems. The firm's revised procedure and form were insufficient, lacking rationale for data analysis methods, procedures for identifying other quality data, documentation of CAPA record review, and employee training. 2. **Failure to maintain complaint files and procedures (21 CFR 820.198(a))**: A CAPA was opened without an associated complaint record. The sales and marketing manual did not instruct on documenting oral complaints, and the feedback form lacked criteria for Medical Device Reportability (MDR) evaluation. Revised procedures for oral feedback and MDR determination were inadequate, and no documentation of MDR reportability evaluation or employee training