# FDA WARNING_LETTER - Pishon Trading Inc - August 01, 2012

Source: https://www.keypedia.com/records/warning_letter/pishon-trading-inc/d1445fb3-ace0-4e4b-865d-9a2faca7a4fa

> FDA WARNING_LETTER for Pishon Trading Inc on August 01, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Pishon Trading Inc
- Inspection Date: 2012-08-01
- Product Type: Devices
- Office Name: Los Angeles District Office
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)

Company: https://www.keypedia.com/companies/pishon-trading-inc/9f059cd8-09c1-4917-b58b-bad4cc7b7e11

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b