Excelsior Medical Corp – FDA Warning Letter, Aug 21, 2014

This FDA Warning Letter to Excelsior Medical Corporation, dated October 23, 2014, details violations of the Quality System (QS) regulation (21 CFR Part 820) for their Saline and Heparin Flush Syringes, deemed adulterated devices. The inspection occurred from July 21 to August 21, 2014.

Key violations include: 1. **Failure to implement corrective and preventive action (CAPA) procedures (21 CFR 820.100(a))**: The firm did not verify the effectiveness of CAPAs, leading to reoccurring contamination issues from a vendor. 2. **Failure to prevent contamination (21 CFR 820.70(e))**: Daily cleaning records for clean room C did not document required wipe-downs and mat replacements. 3. **Failure to maintain personnel health and cleanliness requirements (21 CFR 820.70(d))**: An employee was observed without required footwear in a designated area leading to a cleanroom. 4. **Failure to maintain a design history file (DHF) (21 CFR 820.30(j))**: The firm did not retain batch records supporting stability studies for product shelf life, lacking assurance of design conformity. 5. **Failure to validate device design (21 CFR 820.30(g