FDA 483 - Professional Pharmacy Services Inc dba Good Day Pharmacy - June 17, 2019

This FDA Form 483 was issued to Professional Pharmacy Services Inc dba Good Day Pharmacy, a non-sterile drug manufacturer located at 1749 Main St Unit D, Longmont, CO 80501-7441. The inspection occurred from June 10-17, 2019, and the report was issued to CEO Vickilee K. Einhellig.

Two observations were noted:

1. **Inadequate Containment and Cleaning for Highly Potent Drugs:** The firm produced highly potent drugs without adequate containment, segregation, cleaning of work surfaces, and cleaning of utensils to prevent cross-contamination. Equipment, work surfaces, and utensils are shared between hormonal and non-hormonal products at both the Longmont and Fort Collins locations. The firm failed to demonstrate that dishwasher and manual cleaning (soap and water) are adequate to mitigate cross-contamination. Non-dedicated equipment includes a hood, compounding counter, glass stirrers, metal spatulas, glass mortar and pestle, mesh sieves, capsule machines, unguator and mixing blades, ointment mill, troche mold, stir bars, and beakers. Specific examples from June 4 and June 7, 2019, detail the co-production of various hormone-containing and non-hormone-containing prescription products using shared equipment.

2. **Use of Non-Pharmaceutical Grade Component:** The firm used a non-pharm