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# Poor Inspection Leads to Ocular Therapeutix NDA Complete ‘Response’
- URL: https://www.fdaweb.com/poor-inspection-leads-to-ocular-therapeutix-nda-complete-response/
- Published: 2016-07-25T12:00:00.000Z
- Updated: 2026-09-14T21:16:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136263

Deficiencies cited during a preapproval inspection at an Ocular Therapeutix manufacturing facility has led to a FDA complete response letter for its NDA on Dextenza (dexamethasone insert) 0.4 mg, for intracanalicular use in treating ocular pain occurring after ophthalmic surgery. The letter raised concerns pertaining to unspecified deficiencies in the manufacturing process and controls section of the submission. “Satisfactory resolution of the manufacturing deficiencies identified during the FDA facility inspection is required before the NDA may be approved,” the company says. The letter did not identify any efficacy or safety concerns with respect to the clinical data provided in the NDA, nor any need for additional clinical trials for the approval of the NDA, it notes.