A contaminated water system at one of Torrent Pharmaceuticals’ U.S. manufacturing facilities — and inadequate investigations into failing microbiological results — resulted in a second FDA warning letter for the company in a single month.
The water system at the company’s Levittown, Pennsylvania facility was found to contain Burkholderia cepacia, a group of bacteria that, while mostly harmless to healthy patients, poses risks to hospitalized patients.
Torrent discovered the bacteria after adjusting its sampling and testing procedures in Dec. 2018, isolating B. cepacia in manufacturing equipment rinse samples. Despite the findings, the firm didn’t investigate potentially affected batches that went to market until months after it uncovered the contamination and several weeks after an inspection by the agency.
In addition, the company’s first investigation into the failing microbiological results didn’t account for the water system’s sanitary design deficiencies, which included multiple dead legs and threaded pipe connections. The flaws led a decision to stop using and replace the system.
The FDA also warned the firm for selling phenobarbital oral solution and hydrocortisone acetate suppositories without agency approval.