FDA 483 - Staska Pharmaceuticals, Inc. - September 18, 2024

During an FDA inspection from September 3-18, 2024, Staska Pharmaceuticals, Inc., an outsourcing facility located at 742 Evergreen Dr., Bennet, NE, received a Form 483 with nine observations.

**Quality System Observations:** 1. **Inadequate Discrepancy Review:** The firm failed to thoroughly investigate unexplained discrepancies and batch failures. For Buffered Lidocaine HCl USP 2% 20mg/mL, 50mL Vials, rejected due to defects, the investigation into contamination and transport damage was not expanded to other affected lots. No firm-implemented CAPAs or effectiveness checks were conducted. Similarly, for Ascorbic Acid 500mg/mL 50mL Vials with glass particles, the investigation was not expanded to all amber vial lots, and an in-house testing SOP remains in draft. Batches were released without established defect limits. 2. **Lack of Acceptance Criteria:** The firm has not established adequate acceptance criteria for quality control testing, specifically for 100% visual inspection of finished products. There is no clear classification scheme for defects (critical, major, minor) or established rejection rates. 3. **Insufficient Employee Training:** Employees lack required training for visual inspection. There's no clear defect classification, documented defect characterizations (size, location, photos), or incorporation of routinely encountered defects into training. No limit for false rejections is