FDA 483 - Kings Park Slope Inc - September 14, 2018

This FDA Form 483 documents observations from an inspection of Kings Park Slope Inc, a 503A compounding pharmacy located at 357 Flatbush Ave, Brooklyn, NY, conducted from August 21 to September 14, 2018. The report was issued to Dmitry Vagman, Pharmacist in Charge and Vice President.

Four observations were noted:

1. **Inadequate use of sporicidal agents in ISO 5 aseptic processing areas:** Pharmacy technicians were observed cleaning laminar flow hoods incorrectly (side-to-side instead of back-to-front) and using sporicidal agents in an improper sequence. 2. **Non-sterile disinfecting agents and cleaning wipes:** Wipes used for cleaning/disinfecting ISO 5 hoods were not sterilized prior to use in aseptic processing areas. 3. **Poor facility design allowing influx of poor quality air (Repeat Observation):** The firm exhibited inadequate pressure differentials between cleanroom areas. Specifically, out-of-specification negative pressure readings were observed for the ISO 7 hazardous cleanroom for over nine minutes on July 13, 2018, during which a drug product (Daratumumab 20mg/mL) was produced. No investigation was initiated for this loss of negative pressure. Additionally, reviews of pressure differential logs by the pharmacist in charge or designee were not documented. 4. **Inadequate media fills (Repeat