FDA 483 - Precision Pharmacy Center, LLC - June 10, 2016

This FDA Form 483 document details observations from an inspection of a drug product manufacturing facility. The primary issues identified relate to quality control and stability testing for sterile injectable drug products.

A significant observation is the failure to adequately test drug products purporting to be pyrogen-free. Specifically, endotoxin testing is not performed for some sterile drug products, and the facility lacks established specifications for endotoxin levels in finished sterile injectable drug products. An example cited is Hydroxyprogesterone caproate 280mg/ml oil solution Injectable, which was not tested for endotoxin levels and had no endotoxin specification. Bimix (PAPV/Phent) 30mg/2mg per ml Injectable was tested for endotoxin, but also lacked a defined specification.

Furthermore, the facility does not have a written testing program to assess drug product stability characteristics, a repeat observation. The procedure for assigning Beyond Use Dates (BUDs) does not specifically address sterile drug products, and sterile drug preparations lack complete data to support extended BUDs. For instance, Hydroxyprogesterone caproate 280mg/ml oil solution Injectable (with preservatives) has a 60-day ambient temperature BUD, but the supporting data is incomplete.