FDA 483 - Buderer Drug Company Inc - July 24, 2017

This FDA Form 483 documents observations made during an inspection of Buderer Drug Company, Inc., a producer of sterile drug products located at 26611 North Dixie Highway, Suite 119, Perrysburg, OH 43551. The inspection was conducted from July 17, 2017, to July 24, 2017. The report was issued to Matthew J. Buderer, Vice President.

Three observations were noted: 1. **Drug Product Quality Deficiency:** The firm released drug product (Sodium Tetradecyl Sulfate, Straight Chain 3% 30ml Vascular Injection MDV) where retained sample vials from all batches produced to date contained tiny white particulates, indicating the strength, purity, or quality fell below represented standards. No investigation was performed to determine the cause of these failures. 2. **Improper Gowning and Aseptic Technique:** Personnel donned non-sterile gowning apparel improperly, potentially causing contamination, and were observed with exposed skin during aseptic processing. Gowns worn by technicians producing sterile drug products were non-sterile, including sleeves entering the ISO 5 area, and were removed in the ISO 8 area and re-used throughout the day. 3. **Inadequate Environmental Monitoring and Facility Design:** Pressure differentials between areas with different air classifications were not monitored prior to or during sterile drug production. Additionally, a gap in the doors of