Maag Prescription Center LLC – FDA 483, Sep 28, 2018

The FDA Form 483 details significant violations at a drug compounding facility. The firm used non-pharmaceutical grade components, including retail grocery store items like (b) (4) (b) (4) and (b) (4) (b) (4), in numerous drug formulations for both individual patients (e.g., Glycopyrrolate oral suspension, Budesonide oral suspension) and office stock (e.g., Trichloroacetic Acid 80%).

Additionally, the firm produced hazardous drugs without adequate containment, segregation, or cleaning procedures. Their cleaning process for work surfaces and shared equipment involved household soap and water, with some tools sprayed with (b) (4) and surfaces cleaned with (b) (4), which is deemed insufficient to prevent cross-contamination. Examples include producing various hazardous drugs (e.g., Progesterone/Testosterone cream, Fluorouracil cream) without adequate cleaning between batches. The firm also failed to adequately clean shared production tools and areas when switching between hazardous and non-hazardous drugs, and did not require appropriate personal protective equipment (gowns, eye protection, face masks) for staff during hazardous drug production.

Further contamination risks were observed, such as an operator touching a bare wrist with a spatula and continuing to use it without cleaning, and washing utensils with scented household soap. Mixing tools were also found to be unsuitable, with cracked wooden handles, green discolorations, and rusty screws, posing a risk of