FDA WARNING_LETTER - Safecross First Aid Ltd - January 24, 2013

On January 23-24, 2013, an FDA inspection of Safecross First Aid Ltd. in Toronto, Canada, identified violations regarding first aid kits and components, classified as devices. The firm's products were deemed misbranded under 21 U.S.C. § 352(t)(2) for failing to provide required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting).

Specific violations include: 1. Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. The existing procedure only covered Health Canada guidelines and omitted FDA MDR requirements. 2. Failure to maintain complaint files and establish procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR 820.198(a). Reports of issues were not classified as complaints, and the "Products Complaints Binder" was empty. 3. Failure of management to review the suitability and effectiveness of the quality system at defined intervals, as required by 21 CFR 820.20(c). No documentation of management reviews was available. 4. Failure to establish procedures for quality audits and conduct such audits to ensure quality system compliance and effectiveness, as required by 21 CFR