FDA 483 - Kelley-Ross & Associates, Inc. dba Kelley-Ross Compounding Pharmacy - September 23, 2020

This FDA Form 483 documents observations from an inspection related to the sterile production of Epinephrine/Ketorolac/Ropivicaine 0.0006%/0.03%/0.2% and non-sterile production of cytotoxic drugs.

Key violations include: 1. **Inadequate Disinfection of Materials:** On September 9, 2020, rubber stoppers of vials (Epinephrine, Ketorolac, Ropivicaine, Sodium Chloride) were swabbed with non-sterile wipes prior to use in an ISO 5 Biosafety Cabinet for sterile drug production (Lots 6373, 6368, 6366). The material was then transferred to syringes without further sterilization. 2. **Poor Air Quality/Facility Design:** A July 10, 2019, smoke study showed stagnant smoke in the ISO 7 Hazard Room ceiling, near the ISO 5 Biosafety Cabinet. A June 12, 2018, study indicated smoke flowing from the ISO 7 Hazard Room into the ISO 5 Biosafety Cabinet, demonstrating poor air flow and potential contamination risk. 3. **Dirty Equipment/Surfaces in Aseptic Areas:** On September 11, 2020, the ISO 5 Biosafety Cabinet and surrounding ISO 7 Hazard Room exhibited visibly dirty surfaces, including white residue