FDA 483 - Avella of Deer Valley, Inc. Store 38 - April 20, 2018

The FDA Form 483 inspection of an outsourcing facility revealed several deficiencies. Aseptic processing areas were found deficient, specifically regarding alarm settings for non-viable particle excursions in ISO 5 classified laminar flow hoods and biological safety cabinets. The firm's SOP 03HVOS-014 specifies limits of (b)(4) non-viable particles per (b)(4) size and (b)(4) non-viable particles per (b)(4) size, but alarms were set at (b)(4) non-viable particles per (b)(4).

The quality control unit's responsibilities and procedures were not fully followed. Production technicians did not visually inspect sterile products during packaging and labeling operations for products like Magnesium Sulfate, Phenylephrine, and Vancomycin, violating SOP 03HVOS-037. HEPA leak testing on filters maintaining ISO 7 environments had not been performed since November 2016, and SOPs lacked recertification requirements. Vendor reassessments, such as for (b)(4) (growth media) and (b)(4) (vials), were overdue per SOP 03HVOS-GEN-011.

Drug products were not stored under appropriate temperature and humidity conditions. Monitoring only began in February 2018, despite products being stored since April 2017, and scientific justification for the single warehouse probe placement was lacking.

Finally