FDA WARNING_LETTER - EMcision Ltd. - August 14, 2014

On November 20, 2014, the FDA issued a Warning Letter to EMcision Ltd. following an inspection from August 11-14, 2014. The inspection found that the firm's device, Habib EndoHPB, was misbranded under Section 502(t)(2) of the Act due to failure to furnish required information under Section 519 and 21 CFR Part 803 (Medical Device Reporting - MDR).

Significant deviations included the failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. The firm's MDR procedure lacked internal systems for timely identification, communication, and evaluation of events, a standardized review process for reportability, and instructions for timely transmission of complete reports (e.g., FDA 3500A form completion). It also failed to describe how documentation and record-keeping requirements for adverse events, reportability evaluations, decision-making processes, and access to information for follow-up would be addressed.

Additionally, the firm had quality system deficiencies under 21 CFR Part 820, including: 1. Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)), lacking requirements for analyzing quality data, implementing changes, and identifying actions to prevent recurrence. 2. Failure to maintain complaint files and establish/maintain