FDA 483 - Ranier's Compounding Laboratory - May 22, 2018

This FDA Form 483 details multiple observations from an inspection, highlighting significant deficiencies in aseptic processing, environmental control, and quality systems.

**Violations and Observations:**

* **Aseptic Technique Breaches:** Personnel touched non-sterile surfaces and then engaged in aseptic processing without glove changes or sanitization (e.g., Lido/Dex/Hep/Gent/Sodium Bicarbonate Bladder Irrigation Solution lot 051518-1CR). Exposed hair was observed in the ISO 5 hood during production of multiple lots (e.g., Cefazolin 50 mg/mL Ophthalmic solution lot 151618-1CR, Tobramycin 14 mg/mL Ophthalmic solution lot 151618-2CR). * **Disinfection Failures:** Components were handled with bare hands before and during disinfection. Non-sterile pliers were introduced into the ISO 5 critical zone without disinfection. Sporicidal agents used in the ISO 5 area were inadequate in concentration/contact time. Disinfecting agents (e.g., (b)(4)) and cleaning wipes used in the ISO 5 area were not sterile. * **Facility Design and Operation:** Poor personnel and material flow was observed. The unclassified Prep room, storing sterilized glassware, had technicians moving between it and ISO 8/unclassified areas through unclean plastic curtains. Un-gowned personnel (