Pet Pharmacy NW LLC – FDA 483, Jan 28, 2019

This FDA Form 483 details multiple deficiencies observed during an inspection of a facility producing sterile and non-sterile drug products for office stock.

**Key Violations and Observations:**

* **Aseptic Technique Deficiencies:** On 12/10/2018, a sterile drug technician demonstrated inadequate aseptic technique during non-sterile to sterile drug production. Issues included: * Mixing drug components in non-depyrogenated equipment. * Disinfecting equipment with non-sterile wipes and non-sterile solutions. * Jewelry not removed prior to donning sterile gloves. * Improper sterile glove donning. * No disinfection of the LAFH prior to production. * Operator leaning into LAFH with improperly worn facial protection. * Crimping equipment used outside the ISO classified zone without prior disinfection of tools, vial cap, or gloves. * **Media Fills and Smoke Studies:** Media fills do not include the most challenging processes, and dynamic smoke studies have not been conducted to demonstrate airflow during production. * **Environmental Monitoring Deficiencies:** * Sterile drug production occurred after observing water dripping from a cleanroom ceiling tile, which was removed but not re-installed and sealed prior to production. Room re-certification was delayed for approximately (b)(4) days. * Pressure differentials between classified and unclassified areas are