FDA 483 - Randol Mill Pharmacy - August 06, 2019

Pandol Mill Pharmacy in Arlington, TX, was inspected by the FDA from July 23 to August 6, 2019, and received a Form 483 with seven observations. The inspection revealed significant deficiencies in aseptic processing, facility design, contamination control, and quality control procedures for sterile drug products. These issues indicate a high risk of microbiological contamination and compromised product quality.