FDA 483 - M Drug, LLC dba Northern Light Pharmacy - July 19, 2019

This FDA Form 483 details observations from an inspection of M Drug, LLC dba Northern Light Pharmacy, a producer of drug products, located at 210 State St, Bangor, ME, conducted from July 16-19, 2019. Lucas J. Bayne, Pharmacist in Charge, was the individual to whom the report was issued.

**Observation 1** notes the production of hazardous drugs, specifically Tacrolimus, without adequate containment, segregation, or cleaning to prevent cross-contamination. Deficiencies include no designed airflow control or engineered containment for open processing, exposed non-dedicated compounding equipment, inadequate cleaning methods for non-dedicated utensils and work surfaces to remove drug residues, and no designed airflow direction or pressure differential between the compounding room and adjacent areas to contain hazardous substances.

**Observation 2** identifies facility design issues allowing poor quality air into a higher classified area. The compounding facility lacks adequate control of microorganisms and particulates. Specific issues include a window-mounted air conditioner with visible particulate residues and gaps, no pre-filtration of intake air, personnel not required to wear hair covers, a chipped shelf, and product contact utensils with wood handles, all making cleaning challenging.

**Observation 3** states the firm released drug product where the strength, purity, or quality was deficient. This includes a lack of data to show the electronic balance used for weighing active pharmaceutical ingredients (APIs) provides accurate and repeatable results. The balance