FDA 483 - STAQ Pharma of Ohio, LLC - May 16, 2025

An FDA inspection of STAQ Pharma of Ohio, LLC, an outsourcing facility located at 255 Phillipi Rd, Columbus, OH, was conducted from May 6-16, 2025. The inspection identified three observations.

Observation 1 notes a failure to thoroughly review batch failures. Specifically, the firm did not investigate the root cause of critical defects, including particulate matter, found during visual inspections of Dexmedetomidine Hydrochloride 4 mcg/mL, 5mL in a 5mL syringe, Lot [b][4]. Despite an initial 100% visual inspection identifying 85 defects (74 critical) and a subsequent failed AQL inspection, no root cause investigation was initiated. A second 100% visual inspection found 94 defects (87 critical), yet the lot was released and distributed. The orange particulate matter was not characterized, and no corrective actions were implemented.

Observation 2 states the firm failed to establish adequate written procedures for production and process controls. The "Sampling Plans" SOP-0052 does not define reinspection parameters, lacks scientifically sound acceptance criteria post-reinspection, and does not require rejection of lots failing initial AQL. The "Visual Inspection – OH" SOP-0012 lacks acceptance criteria for defect categories (critical, major, minor) and does not require defect trending. Additionally, the use of [b][4] for inspecting colored (amber)