Pishon Trading Inc – FDA Warning Letter, Aug 1, 2012

This FDA Warning Letter, dated January 30, 2013, addresses Pishon Trading Inc dba Eyezone following inspections on November 22-December 7, 2011, and July 18-August 1, 2012. The firm imports and distributes soft contact lenses, classified as devices.

Violations include: 1. **Misbranding (21 U.S.C. § 352(t)(2))**: Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17). The firm confirmed no MDR procedure existed, and its October 26, 2012, response was inadequate. 2. **Misbranding (21 U.S.C. § 352(f)(1))**: Device labeling lacks adequate directions for use. Labels were paraphrased, incomplete, and inaccurate, missing a professional fitting guide, patient care instructions (cleaning, disinfection, wearing schedules), and specific precautions/warnings (e.g., eye infection response, solution reuse, rubbing/rinsing, water storage). 3. **Quality System Deficiencies (21 U.S.C. § 351(h) and 21 CFR Part 820)**: Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints