John W Hollis Inc – FDA 483, Mar 21, 2014

This FDA Form 483 was issued to John W. Hollis Inc dba John Hollis Pharmacy, a producer of sterile drug products, located at 110 20th Avenue North, Nashville, TN. The inspection occurred from February 4, 2014, to March 21, 2014.

The inspection revealed eleven observations:

1. **Lack of Sterilization Process Validation:** Procedures to prevent microbiological contamination of sterile drug products lack validation of the sterilization process. This includes no data for autoclave sterilization of containers/closures/equipment (e.g., endotoxin burden, temperature mapping, heat penetration), no documentation of critical process parameters, and unvalidated storage times for autoclaved items. Components for injectable products are not qualified for endotoxin removal or compatibility, and are mixed in an uncontrolled environment. Bioburden load studies are absent. Endotoxin testing is not performed on each injectable drug product batch, and records are not maintained. Smoke studies for the laminar air flow hood (LAFH) are not performed. The incubator for sterility testing lacks continuous temperature monitoring and positive/negative controls. Media fill procedures are not representative of the most challenging aseptic processes (e.g., filling up to 500 vials vs. 100 vials tested) and were only recently initiated.

2. **Unsuitable Drug Product Containers and Closures:** Containers and closures for injectable drug products are not depyrogenated, and no