FDA 483 - Green Hills Health and Wellness Pharmacy Inc - October 22, 2014

Green Hills Health and Wellness Pharmacy Inc. received an FDA Form 483 following an inspection from October 14 to October 22, 2014, concerning its sterile drug product manufacturing operations. The inspection revealed fundamental deficiencies in the company's controls for sterile drug production.

Key observations highlighted inadequate validation of sterilization processes, with simulation tests (media fills) failing to represent the entire production process or worst-case conditions. The facility used non-sterile cleaning agents in critical sterile processing environments. Environmental monitoring was significantly lacking; surface, air, and personnel monitoring were not performed daily, and disinfectant neutralizers were omitted from samples. Additionally, air pressure in classified areas was not continuously monitored during production.

The company's product testing and release procedures were also found deficient. Potency, sterility, and endotoxin testing were not consistently performed on every lot of sterile drug products, and some products were distributed before receiving confirmatory test results. Furthermore, there was no established stability program to support assigned Beyond Use Dates for sterile products, nor were hold time studies conducted for autoclaved equipment. The company is required to implement comprehensive corrective and preventive actions to address these critical issues, thereby ensuring the safety, quality, and integrity of its sterile drug products.