pharmarive inc ( – FDA 483, Nov 14, 2019

An FDA inspection of Pharmaview Inc, operating as Far Hills Pharmacy, located in Bedminster, NJ, was conducted from October 28 to November 14, 2019. The inspection, focused on the production of non-sterile drugs, resulted in two significant observations, highlighting critical issues in manufacturing practices. First, inspectors observed inadequate containment and cleaning procedures for multi-use equipment during the compounding of hazardous drugs, specifically Estradiol and Testosterone formulations. This raised concerns about potential cross-contamination among drug products. Second, the firm was found to be using non-pharmaceutical grade components in various non-sterile drug formulations, including Biestrogen + Testosterone in Phyto Base, Pyridoxine Suspension, and Minoxidil Scalp Solution, without sufficient assurance of their quality compliance. These observations, issued under the FDA's regulatory framework for drug manufacturing, indicate a need for immediate corrective action to ensure product safety and quality. Pharmaview Inc is expected to provide a timely response detailing its plans to address these deficiencies and prevent their recurrence.