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

This FDA Form 483 details observations from an inspection concerning the production of Tri-Mix (Prost/Pap/Phent 10 mcg/30 mg/1 mg/mL) injectable.

Key violations include: 1. **Inadequate Disinfection:** On 7/17/2017, non-sterile materials for Tri-Mix production (Lot (b)(6)) were placed directly into an ISO-5 biological safety cabinet (BSC) without proper disinfection of the outer surface. 2. **Dirty/Damaged Equipment & Facilities:** * Residue was observed on HEPA filter screens in ISO 7 Prep Area and Anteroom. * Residue was found on the exterior of a balance in the ISO 7 Prep Area. * Three cracks (2.5, 8, and 3.5 inches) were noted on a glass window between the ISO 7 Anteroom and ISO 7 Positive Pressure Room. 3. **Expired ISO-5 Certifications:** From 6/2/2017 to 7/19/2017, 72 sterile drug products were made while certifications for two ISO-5 units (BSC in Negative Pressure Room and unit in Positive Pressure Room) expired in June 2017. 4. **Lack of Dynamic Airflow Analysis:** In situ air pattern