FDA 483 - Park Avenue Compounding - August 14, 2014

An FDA Form 483 was issued following an inspection of a facility engaged in compounding drug activities. The inspection revealed multiple deficiencies related to personnel gowning, aseptic procedures, environmental monitoring, and batch record keeping.

Personnel gowning was found to be inappropriate, with bouffant caps, shoe covers, surgical masks, and gowns used in the ISO 7 Clean Room and ISO 5 IV Hood not labeled as sterile. These single-use supplies were stored openly. Additionally, personnel were observed wearing jewelry (necklace, rings) and having exposed skin around the neck and face while performing aseptic operations, contrary to the Pharmacy Policy. Goggles were not required.

Procedures to prevent microbiological contamination were not followed. An operator dropped tubing with a needle, allowing it to touch the countertop, then continued compounding. Another operator dropped an IV bag on the clean room floor, picked it up, sprayed it with a disinfectant, rubbed it, and then used it for compounding.

Environmental monitoring was deficient, with no daily air, surface, or personnel monitoring conducted in the ISO 5 IV rooms from April 14 to August 6, 2014, despite compounding sterile products. Only a single swab sample was taken in the hood, and no procedure for environmental or personnel monitoring existed. A smoke study procedure to evaluate the ISO 5 IV hood under dynamic conditions was absent, and no study had been conducted since 2009.

Aseptic processing areas lacked proper