FDA 483 - Snyder Mark Drugs Roselle, Inc. d.b.a. Mark Drugs Pharmacy - May 22, 2017

This FDA Form 483 was issued to Snyder Mark Drugs Roselle, Inc. d.b.a. Mark Drugs Pharmacy, located at 384 E Irving Park Rd, Roselle, IL, 60172-2007. The inspection, conducted from April 26, 2017, to May 22, 2017, identified observations regarding the firm's operations as a producer of non-sterile and sterile drug products.

Six observations were noted: 1. **Inadequate Aseptic Technique:** Procedures to prevent microbiological contamination of sterile drug products are not established, written, or followed, with operators demonstrating inadequate aseptic technique during sterile drug production under laminar airflow. 2. **Inappropriate Personnel Clothing:** Employees wear non-sterile gloves before entering the ISO 7 classified Cleanroom and the ISO 7 classified Room where sterile drug products are produced. 3. **Deficient Environmental Monitoring:** The system for monitoring environmental conditions in aseptic processing areas is deficient, as routine monitoring of cleanroom areas is not performed daily during sterile drug production. 4. **Lack of Stability Testing Program:** There is no written testing program to assess drug product stability. Extended Beyond Use Dates (BUDs) are not supported by studies demonstrating stability for potency, sterility, or preservative effectiveness in the final container. 5. **Lack of Sterility and Pyrogen Testing:** Each batch of