Pharm D Solutions, LLC – FDA 483, Jun 5, 2015

On June 5, 2015, the FDA issued a Form 483 to Pharm D Solutions, LLC, an outsourcing facility located at 1304 S Loop W, Houston, TX. The inspection, conducted from May 28 to June 5, 2015, identified eight observations related to the facility's sterile drug product manufacturing and quality control.

Key violations include:

1. **Inadequate Microbiological Contamination Prevention Procedures:** Media fill simulations were not performed under stressful or challenging conditions, failing to represent actual production (e.g., insufficient vial numbers, incorrect equipment simulation, and lack of dynamic conditions). 2. **Deficient Environmental Monitoring:** The firm's procedures for monitoring the ISO 5 LAF hood were unsuitable. Viable air monitoring and surface sampling were not conducted during production, non-viable particulate testing was not dynamic, and surface monitoring of the pass-through window was not performed. 3. **Insufficient Sterility Testing:** Suitability testing for the sterility test method was not performed, and negative controls were not utilized. 4. **Aseptic Area Equipment Maintenance Deficiencies:** Pressure differentials were not alarmed and checked infrequently. Smoke studies were incomplete, lacked acceptance criteria, and were not performed under dynamic conditions to verify unidirectional airflow. 5. **Incomplete Batch Production Records:** Production records lacked complete descriptions of the production process. 6. **Incomplete