FDA 483 - Avella of Deer Valley dba Avella Specialty Pharmacy - February 25, 2013

The FDA Form 483 details multiple deficiencies at a facility producing sterile drug products, observed during an inspection on February 19, 2013.

**Gowning and Aseptic Technique Deficiencies:** * Technicians wore non-sterile gowns with exposed skin (around eyes and neck) in the ISO 7 cleanroom, contrary to SOP 03-32. * Sterile gloves were donned in the ISO 7 ante-room, with operators observed contacting the outside of sterile gloves with bare hands. * Operators used non-sterile gloves to wipe down ISO 5 biosafety cabinets and materials, then proceeded to conduct aseptic processing with the same gloves after spraying and air drying, without donning new sterile gloves within the ISO 5 environment. * Operators' forearms, covered by non-sterile gowning, were exposed within the ISO 5 environment during aseptic operations.

**Environmental Monitoring Deficiencies:** * Lack of routine viable particulate air monitoring in ISO 5 and ISO 7 environments during aseptic processing (only static condition monitoring by outside contractor). * Lack of active non-viable particulate air monitoring in ISO 5 and ISO 7 environments during aseptic processing (only static condition monitoring during certification). * No active monitoring of differential pressures in cleanrooms during aseptic processing; only static condition monitoring. * Insufficient frequency of personnel monitoring (gloves/arms not sampled after every lot).