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

The FDA Form 483 details significant deficiencies at a sterile drug product manufacturing facility.

**Gowning and Personnel:** - Technicians wore non-sterile gowns with exposed skin (eyes, neck) in ISO 7 cleanrooms, violating SOP 03 S-32. - Sterile gloves were donned in the ISO 7 ante-room, then used to wipe down ISO 5 Biosafety cabinets before aseptic processing, risking contamination. - Operators' forearms, covered by non-sterile gowning, entered ISO 5 environments. - Personnel monitoring (glove/fingertip sampling) was infrequent, not conducted after every lot.

**Environmental Monitoring:** - Inadequate routine viable and non-viable particulate air monitoring in ISO 5 and ISO 7 environments during aseptic processing. Monitoring was primarily static or by external contractors during certification. - No monitoring of cleanroom pressure differentials during aseptic processing; only external contractor monitoring at static conditions. - Insufficient frequency and rotation of surface environmental monitoring in ISO 5 and ISO 7 cleanrooms, not sampling every surface or after each lot.

**Sterilization and Water Systems:** - No written SOP for the in-house sterilization equipment (e.g., for vials); verbal on-the-job training only. - Lack of routine monitoring (e.g., temperature display/recording, data charts) for each sterilization run, only periodic biological indicator processing. - No firm