Triad Rx, Inc. — FDA 483 Findings

Equipment, materials, and/or supplies are not disinfected prior to entering the aseptic processing areas.

Inadequately or un-protected product intended to be sterile was observed to be exposed to lower than ISO 5 quality air.

Cleaning pads or wipes used in the ISO 5 area are not sterile.

Personnel were observed conducting aseptic manipulations or placing equipment/supplies in an area that blocked the movement of first pass air around an open unit, whether before or after it is filled with sterile product.

Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.

The use of sporicidal agents in the cleanrooms and/or ISO 5 area is inadequate or infrequent.

Personnel engaged in aseptic processing were observed with exposed hands, wrists, legs, hair, or mouth.

The ISO-classified areas have difficult to clean, particle-generating, or visibly dirty equipment or surfaces.

Personnel were observed touching equipment or other surfaces located outside ofthe ISO 5 area with gloved hands and then proceeding with aseptic processing without changing or sanitizing gloves.