FDA 483 - Kelley-Ross & Associates, Inc. dba Kelley-Ross Compounding Pharmacy - August 01, 2017

The FDA Form 483 inspection revealed multiple deficiencies in aseptic processing and quality control at the facility.

**Facility and Operations:** The facility produces Tri-Mix (Prost/Pap/Phent 10 mcg/30 mg/1 mg/mL) injectable, with production observed on 7/17/2017 for Lot number (b) (6). Operations involve ISO-5 biological safety cabinets (BSC) and ISO 7 Prep/Anteroom areas.

**Violations and Observations:** * **Disinfection:** Non-sterile materials (plastic bag with in-process materials, containers, closures) were placed directly into an ISO-5 BSC (Serial (b) (4)) without adequate disinfection. * **Cleanliness:** Apparent residue was observed on HEPA filter screens in ISO 7 areas and on the exterior of a (b) (4) balance in the ISO 7 Prep Area. Three cracks (2.5, 8, 3.5 inches) were found on a glass window between the ISO 7 Anteroom and Positive Pressure Room. * **ISO Certification:** ISO-5 BSCs (Serial (b) (4) in Negative Pressure Room and Serial (b) (4) in Positive Pressure Room) had expired certifications (June 2017), yet 72 sterile drug products were made between 6/2/2017 and