McGuff Compounding Pharmacy Services, Inc. – FDA 483, Nov 22, 2019

The FDA Form 483 details multiple observations from an inspection, highlighting significant deficiencies in aseptic processing, facility design, cleaning procedures, and material quality.

During production of chromium injection 200 mcg/ml (lot 19K4111) and sodium bicarbonate injection 8.4% (lot 19L1061), personnel were observed blocking first pass air in the aseptic processing area. HEPA filters in the ISO-5 sterile fill workstation (Room 107) failed integrity leak tests (17% leak, exceeding the allowable limit), with a leak along the housing edge of filter (b)(4), and no investigation into sterile product vials produced since the previous acceptable qualification.

The facility design in Room 111 (ISO-8) and Room 107 (ISO-7) permits poor material flow, with non-sterile polypropylene trays sprayed with non-sterile (b)(4) transferred into ISO-7, then sprayed with sterile (b)(4) without specified contact time or environmental monitoring. Stacking of partially filled trays on full trays of uncapped sterile product was observed.

Sporicidal agent use in the ISO-5 aseptic processing area was inadequate; the stainless-steel benchtop is not disinfected with sterile (b)(4) during (b)(4) cleaning, relying only on (b)(4) fogging (b)(4). Materials, including covered metal trays with empty