FDA 483 - Complete Pharmacy and Medical Solutions, LLC. - August 12, 2014

The FDA Form 483 details significant deficiencies in a firm's control systems for sterile injectable drug products.

**Sterilization and Depyrogenation Issues:** * **Inadequate Container/Closure Sterilization:** The firm lacks an adequate system to ensure proper sterilization and depyrogenation of glass vials and rubber stoppers. * **Lipoclean/MIC-B Complex (#1899) Injectable, lot # 13879:** Failed sterility testing twice due to *Pseudomonas aeruginosa* contamination. Investigation attributed it to operator error in vial sterilization but failed to extend to other potentially affected batches (5/28/14 - 6/3/14) and lacked adequate corrective/preventive action. * **Cyanocobalamin injectable, lot # 13800/C:** Rejected due to particulates from inadequate glassware cleaning. Procedures for glassware cleaning are not established, and the washing machine used showed particulates and mineral residue. * **Rubber Stopper Processing:** Procedures for washing, sterilization, and depyrogenation of rubber stoppers are inadequate. Brown residue was observed on the water dispenser nozzles used for rinsing. No scientific data supports the endotoxin removal process. Pharmacy technicians failed to follow SOP 6.002 regarding rinsing volume, and the SOP lacks specifications for oil residue removal. The specified sterilization method in SOP 6.002 has not been