Pharm D Solutions, LLC – FDA 483, Aug 28, 2018

This FDA Form 483 details multiple deficiencies observed during an inspection.

**Facility and Operations:** The inspection focused on the aseptic compounding of sterile injectable and lyophilized drug products, including Trimix, HCG, Lipo MIC-12, and Testosterone.

**Violations and Observations:**

* **Microbiological Contamination Prevention (Repeat Observation):** * Inadequate smoke studies under dynamic conditions in ISO 5 laminar air flow workbenches (LAFWs), failing to simulate routine production or verify airflow. * Media fills not simulating worst-case activities or challenging aseptic operations. * Numerous aseptic practice deficiencies observed: technicians blocking HEPA airflow, bare skin exposed, leaning into LAFWs, wiping LAFWs over open vials, transporting partially stoppered vials without ISO 5 protection, insufficient drying of sprayed gloves, inadequate spraying of items before introduction into LAFWs, and technicians re-entering cleanroom without re-gowning after touching non-sterile items. * Use of non-pharmaceutical grade components (e.g., (b)(4) instead of (b)(4) USP) in sterile drug compounding.

* **Quality Control Unit Deficiencies:** * Failure to reject sterile drug product batches not meeting potency specifications (e.g., HCG, Lipo MIC-12 lots with out-of-spec or no potency results were released). *