FDA 483 - Loop Plaza Pharmacy Company DBA Loop Compounding Pharmacy - September 25, 2018

On September 19-21 and 24-25, 2018, the FDA inspected Loop Plaza Pharmacy Company DBA Loop Compounding Phar, located at 72 6th Ave, Saint Albans, WV. The firm is a producer of sterile and non-sterile drug products. The inspection revealed four observations.

Observation 1 noted that the ISO 5 classified area is within a non-classified room, lacking assurance of classified conditions for the cleanroom surrounding the ISO 5 laminar air flow hood. The last certification was on February 22, 2018, and was overdue for re-certification, with approximately 200 products produced since September.

Observation 2 identified the use of non-sterilized or non-depyrogenated tools or temporary containers in sterile drug production, specifically for storing bulk solutions. This raises concerns about sterility maintenance for products like Bupivacaine HCl 40mg/ml, Hydromorphone 100mg/ml, Morphine 100mg/ml, and Clonidine HCl 2000 mcg/ml, which are used for patient-specific prescriptions.

Observation 3, a repeat observation from a previous inspection, stated that ISO-5 classified areas were not certified under dynamic conditions. Specifically, no dynamic smoke studies were performed during the February 22, 2018 cleanroom certification to verify unidirectional airflow in the