Hunter Holmes McGuire Veterans Affairs Medical Center Mammography – FDA 483, Mar 11, 2015

On March 9-11, 2015, the FDA inspected Hunter Holmes McGuire Veterans Admin Medical Center in Richmond, VA, a producer of sterile drugs. The inspection revealed three observations.

Observation 1: Procedures to prevent microbiological contamination of sterile drug products are not established and written. Specifically, smoke studies under dynamic conditions have not been conducted in ISO 5 and 7 areas to ensure laminar airflow and assess the impact of operators and equipment. Additionally, media fill (process simulation) lacks positive controls to confirm media growth promotion, and media lots are not tested upon receipt for growth promotion. The facility has not demonstrated that the selected media supports the growth of gram-negative and gram-positive bacteria, yeast, and mold.

Observation 2: Aseptic processing areas have deficient cleaning and disinfection systems. Despite identifying spore-forming microorganisms (e.g., bacillus) in environmental monitoring, sporicidal cleaning agents are not used. A multi-use wet mop was used for ISO 7 area floors, raising concerns about bioburden. Disinfection/cleaning procedures lack directions and schedules for cleaning ISO 7 area ceilings and walls, and the use of all cleaning agents, including non-sterile (b)(4), is not included.

Observation 3: Written records of investigations into unexplained discrepancies are not maintained, and written procedures for thorough investigations are absent. Examples include: no investigation for unrecorded personnel environmental surface sample results from 5/24/2