FDA 483 - LEESAR, INC - July 12, 2017

This FDA Form 483 details deficiencies observed during an inspection of a facility involved in aseptic processing and drug compounding.

**Facility and Operations:** The firm operates aseptic processing areas, including ISO 5, ISO 7, and ISO 8 rooms, and utilizes automated compounding systems (regulated as Class II medical devices).

**Violations and Observations:**

* **Aseptic Processing Deficiencies:** * Use of non-sterile cleaning agents for routine cleaning in ISO 5, ISO 7, and ISO 8 areas. * Pharmacy technicians handling drug components outside the ISO 5 area without sanitizing gloved hands multiple times while loading/unloading compounding systems. * Deficiencies in maintaining aseptic conditions, including: * Airflow studies under dynamic conditions not following vendor protocols. * Airflow studies failing to determine if processing equipment impedes unidirectional airflow in ISO 5 areas. * Room certifications for 2015 and 2016 not accounting for increased personnel in the ISO 7 area. (Repeat Observation) * **Investigation Failures:** * Failure to investigate 3,855 rejections in 2016 and 2,278 rejections in 2017 from compounding systems, primarily due to weight errors or invalid dosing volume (59.30% in 2016,