FDA 483 - Allegheny Health Network Home Infusion, LLC - September 25, 2018

This FDA Form 483 was issued to Allegheny Health Network Home Infusion, LLC, a producer of sterile drugs located at 311 23rd St., Ext., Ste. 500, Sharpsburg, PA 15215. The inspection occurred from September 17-21, 2018, with the 483 issued on September 25, 2018, to Monica A. Lane, Pharmacy Manager.

Two observations were noted: 1. Personnel donned gowning apparel improperly, potentially causing contamination. Specifically, on September 20, 2018, an operator was observed donning a used disposable coverall, allowing the coverall's legs to contact the Ante Room floor. 2. Disinfecting agents and cleaning pads or wipes used in the ISO 5 aseptic processing area were not sterile. On September 17, 2018, non-sterile lint-free wipes were applied to surfaces within the ISO 5 area of the workbench in the non-hazard clean room, where sterile products like Milrinone 0.8mg/ml and Methylprednisolone 1g/100ml were produced.