STERRX

About STERRX

STERRX, founded in 2013 by Dr. Gary Hanley, operated as a privately held manufacturer of sterile liquid pharmaceuticals based in Plattsburgh, New York. The company established itself as a contract manufacturing organization, registered with the FDA under section 503b, to provide compounded sterile drug products. Its client base primarily consisted of hospitals, clinics, and doctor's offices.

The company's production process centered on the use of automated blow-fill-seal machines. This technology was designed to create plastic packaging from resin and fill each unit within a sterile, enclosed environment, thereby aiming to eliminate human contact and reduce the potential for contamination. SterRx's capabilities included manufacturing a variety of products such as single-dose vials, ophthalmic doses, and pre-filled syringes and IV bags ranging from 50 mL to one liter.

A significant milestone in the company's trajectory was securing a contract award valued at an estimated $1 billion, which fueled a period of rapid expansion. This growth included leasing a 60,000-square-foot warehouse to complement its existing 50,000-square-foot manufacturing plant. However, the company's operations encountered substantial difficulties. In 2021, SterRx initiated a voluntary recall for three lots of sodium bicarbonate due to microbial contamination. This was followed by a much larger recall of approximately 240 lots of various products due to equipment and process issues that compromised sterility assurance. FDA inspections uncovered "serious deficiencies" in its sterile production practices, leading to a warning letter in July 2022 that detailed issues such as insanitary conditions and substandard manufacturing processes.

Citing economic reasons, SterRx officially closed its Plattsburgh facilities in August 2023, resulting in the layoff of its entire 161-person workforce. The closure followed the acquisition of SterRx's parent company, Sagent, by another global pharmaceutical firm that chose to focus on other lines of business.