FDA 483 - Dignity Health - Northridge Hospital Medical Center - March 11, 2016

The FDA Form 483 details numerous deficiencies at an unnamed facility involved in aseptic processing of sterile drug products, including TPN production and Labetalol HCl 5 mg/ml injection.

Key violations include an inadequate environmental monitoring program, with active, passive, and non-viable air monitoring not conducted daily, and personnel not monitored after each shift. The aseptic processing areas lack proper equipment for maintaining aseptic conditions: no designated anteroom, an unqualified ISO 7 IV Room since (b)(4), plastic strip curtains instead of doors for the ISO 7 room, and a sink inside the ISO 7 room.

Procedures to prevent microbiological contamination are not followed, evidenced by a lack of process simulation for TPN, technicians moving materials without (b)(4) and returning to ISO 5 without sanitizing gloves. Air supply deficiencies include no static/dynamic smoke studies, no pressure differential gauges, and no established minimal airflow velocity.

Facility maintenance is poor, with dirty trolleys in the ISO 7 room. Personnel gowning is inappropriate, lacking sterile components, and observed instances of incomplete or absent gowning. The ISO 7 room ceiling has unsealed fire sprinkler heads and an unsealed access door, with gaps between the ceiling and air duct.

There is no written stability testing program for drug products like Labetalol HCl. Cleaning and disinfection are deficient, lacking documentation of sporicidal agent use, effectiveness studies for sanitizers/disinfectants, and