FDA 483 - Westlab Pharmacy, Inc. dba Westlab Pharmacy - August 15, 2018

The FDA Form 483 details multiple observations from an inspection. The facility's ISO 5 classified aseptic processing area, used for mitomycin and cyclosporine drug products (e.g., Mitomycin Oph 0.02% Lot 06152018@13, Cyclosporin Aqueous 0.5% solution Lot 06132018@43), was located within a non-classified room. Non-sterile disinfecting agents and cleaning wipes were used in ISO 5 areas; specifically, non-sterile wipes were used to clean the ISO 5 Laminar Airflow Workstation (LAFW) prior to a media fill on 08/06/18, and non-sterile products like (b)(4) were used for cleaning.

Non-pharmaceutical grade components were used in drug product formulations, including (b)(4) in Alprostadil 500mcg/mL injectable (Lots 03182018@42, 07252018@17), and in non-sterile products such as Vancomycin/Water 250mg/mL solution (Lot 07022018@53). Personnel engaged in aseptic processing were observed with exposed hands, specifically an operator donning sterile gloves inside the ISO 5 LAFW. The ISO 5 LAFW had difficult-