(Reuters) - Specialty Compounding Llc reached a settlement with the U.S. Food and Drug Administration on Wednesday, barring the company from producing and selling sterile drugs until it receives written approval from the agency.
The FDA filed a complaint with the U.S. District Court for the Western District of Texas in February, alleging that one of Specialty Compounding’s sterile injectable drugs had tested positive for bacterial contamination.
As part of the deal, Specialty Compounding settled all litigation without an admission of guilt, but cannot resume producing, holding or selling sterile drugs until it receives written approval from the FDA.
The company recalled batches of sterile drugs in August 2013, after the FDA received reports of 17 patients developing bacterial infections after being given an infusion of calcium gluconate made by the company.
The FDA inspected the company’s Cedar Park facility in Texas in August and September 2013, and found unsanitary conditions and numerous other violations.
“Specialty Compounding’s manufacturing practices posed a serious risk to the public health,” Acting Assistant Attorney General Benjamin Mizer of the Justice Department said.
Specialty Compounding, co-owned by Raymond Solano, III and William Swail, makes both sterile and non-sterile drugs, and distributes its products to hospitals, surgery centers and clinics across the United States.
Reporting by Natalie Grover in Bengaluru; Editing by Simon Jennings