FDA 483 - John L. McClellan Memorial Veterans Hospital - January 23, 2020

This FDA Form 483 document details observations from an inspection of John L. McClellan Memorial Veterans Hospital, a producer of sterile drug products, located at 4300 W 7th St Rm 1D100, Little Rock, AR 72205-5446. The inspection occurred from January 13-17, 2020, and January 21-23, 2020. Dr. Margie A. Scott, Medical Center Director, was the individual to whom the report was issued.

The inspection revealed eight observations:

1. **Non-sterile Disinfecting Agents and Wipes:** Disinfecting agents and cleaning wipes used in ISO 5 classified aseptic processing areas were not sterile. This included non-sterile [b)(4)] used for routine cleaning of biological safety cabinets (ISO-5), non-sterile bactericidal [b)(4)] cleaning solution for routine cleanings of classified areas, and non-sterile [b)(4)] Wipes [b)(4)] used as a fungicidal for material transfer into aseptic operations. The firm produces various sterile drug products, including intravenous, subcutaneous, and intrathecal routes of administration.

2. **Inadequate Product Evaluation and Remedial Action for Microbial Contamination:** The firm did not adequately evaluate and take remedial action when actionable microbial contamination (11 CFUs of Gram-positive rods, micrococ