FDA 483 - rms Company - September 12, 2025

rma Company in Minneapolis, MN was inspected from 9/10/2025 to 9/12/2025 and received a Form FDA 483 with two observations. The inspection revealed deficiencies in establishing adequate procedures for environmental control, including insufficient documentation of investigations for cleanroom and endotoxin monitoring excursions, and improper recording of cleanroom pressure. Additionally, the firm's corrective and preventive actions were found to be inadequate to prevent recurrence of cleanroom monitoring issues.