FDA 483 - Anderson Holdings Inc. - February 19, 2016

This FDA Form 483 details deficiencies at a facility producing sterile drug products, including Cyclosporin 2% ophthalmic solution and Tri-Mix 30-1-10.

**Aseptic Processing Area Deficiencies:** * **Cleaning and Disinfection:** The ISO 5 glove box's front panel is fully opened for daily cleaning, exposing the aseptic area to non-sterile gowning and ISO 8 room air without impact evaluation. Non-sterile solutions (Process LpH st, Vespelne Ise, Sporicidin) and non-sterile, non-shedding wipes are used in the ISO 5 glove box. Dilution of cleaning agents (Process LpH st, Vespelne Ise) with distilled water is not documented. Cleaning logs lack specific cleaning agent documentation for daily/monthly cleanings of ISO 5 and ISO 8 areas. * **Environmental Monitoring:** Volumetric viable air and surface contact monitoring in ISO classified areas are only monthly; no routine monitoring of the ISO 5 glove box during aseptic operations (3-4 days/week). Personnel monitoring (fingertip plating) is only during semi-annual media fills, not after routine sterile processing, and does not adhere to the specified frequency. ISO 8 room air pressure is documented daily, but continuous pressure differential monitoring for the ISO 5 glove box is absent. Positive low-level viable air monitoring results in the ISO 8 clean