FDA 483 - June R.R. Nichols, Ocularist, Ltd - April 11, 2025

An FDA inspection of June R.R. Nichols, Ocularist, Ltd, a manufacturer of Class 2 Scleral Shells, identified two significant quality system deficiencies. The firm failed to establish procedures for quality audits, with the president responsible for all matters also conducting internal audits, which violates regulations. Additionally, the company lacked established and implemented procedures for management review.