FDA EIR - Ortec, Inc. - February 10, 2022

Ortec, Inc. underwent an FDA Pre-Approval and initial Current Good Manufacturing Practice (cGMP) inspection at its Piedmont, SC facility from February 7-10, 2022. The inspection assessed the company's ability to contract manufacture a pharmaceutical component for an FDA-regulated medical device, specifically a contact lens package component. This evaluation was conducted under compliance programs governing Pre-Approval and Drug Manufacturing Inspections, with the manufactured product subject to the Food, Drug, and Cosmetic Act. While no formal FDA Form 483 (Inspectional Observations) was issued, a verbal observation was discussed with management. This related to a noticeable incidence of initial errors in laboratory documentation, though these were consistently identified and corrected by quality control before final review. The firm was advised to critically evaluate its training program, laboratory techniques, and documentation practices to reduce these initial discrepancies. No formal corrective actions were mandated, but the FDA emphasized that its final determination could lead to more substantial regulatory actions upon comprehensive review.