FDA 483 - Pine Pharmaceuticals, LLC - September 19, 2023

This FDA Form 483 details significant deficiencies at an outsourcing facility, primarily concerning quality control, sterile manufacturing, and reporting.

**Quality Control Unit Deficiencies:** The quality control unit lacks adequate authority and responsibility. * **EPI-CAINE 0.025%-0.75% INJ (IML) SDV, Lot# (b) (4):** Released despite 3% "all other defects" (including 5 visible particulate and 11 seal defects) without root cause investigation. * **TROPI-PHEN (b) (4) OPHTH SOL (15 mL) Lot# (b) (4):** Released after failing 1st and 2nd AQL inspections, following an unjustified procedure change reclassifying particulate matter from critical to major. * **Inadequate Acceptance Criteria:** No scientific justification for moving to a 2nd 100% Visual Inspection (VI) when 1st 100% and AQL fail. Multiple batches with critical defects (e.g., particulate matter) were released without proper identification or assurance of freedom from further particulate matter.

**Failure to Thoroughly Review Batch Failures:** * **LIDO-PHEN 1%-1.5% (IML) SDV Lot# (b) (4):** Released after failing two 100% visual and AQL inspections, then