FDA 483 - Montana Compounding Pharmacy P.C. - September 20, 2016

During an FDA inspection, several deficiencies were noted in the production of non-sterile drug products. Non-pharmaceutical grade components, specifically (b) (4) and (b) (4), were used in formulations like oral suspensions and intranasal preparations. The (b) (4) was dispensed from a 5-gallon water bottle in the employee break room. A non-pharmaceutical grade (b) (4) marker was applied directly to drug capsules, with no control to prevent material penetration.

Vermin, specifically a fly, was observed in the production area on August 30, 2016, hovering over in-process drugs and the operator during capsule filling. Non-microbial contamination was evident due to a missing section of a dust-covered HVAC louver blade, allowing uncontrolled airflow and particulates into active pharmaceutical ingredients.

Hazardous and highly potent drugs were produced without adequate containment, segregation, or cleaning. No dedicated area existed for production or cleaning. On August 30 and 31, 2016, work surfaces were not cleaned prior to weighing, staging, or mixing components for drugs like Thyroid USP and Estradiol capsules, in a shared workspace. An unlabeled, reusable syringe, reportedly used multiple times, was found secured to a component container. The use of non-pharmaceutical grade (b) (4) as a preservative was a repeat observation.