In August, Torrent Pharmaceuticals recalled dozens of lots of over-the-counter cough syrups, nasal sprays and rectal suppositories that put children and adults at risk of bacterial infection. Now, the FDA has lambasted the Indian drugmaker for a poorly designed water system that it said was the source of the bacteria.
In a warning letter posted Tuesday, the FDA said the water system at the plant in Levittown, Pennsylvania tested positive for Burkholderia cepacia after the bacteria was discovered in manufacturing equipment rinse samples.
The drugmaker blamed the problem on the multiple dead legs and poor fittings of the system. It said it would replace it, but the FDA said it had not shown that the temporary system it intended to use in the meantime would meet FDA standards.
In addition, the FDA warning letter said the drugmaker was selling a phenobarbital oral solution USP and hydrocortisone acetate suppositories that had not been approved by the agency.
Torrent in August recalled dozens of medicines, including children's cough medicines and adult suppositories and nasal sprays. Torrent did not receive any reports of infections but the FDA said the company would do well to get an outside consultant to help it with its upgrades.
In 2016, the FDA blamed an outbreak of Burkholderia cepacia on the water system of Florida-based CMO PharmaTech. In all, 60 people in eight states became infected, including ventilated cystic fibrosis patients after they were given a constipation drug made by the CMO.
This was the second warning letter issued to Torrent in one month. In October, the FDA also cited a Torrent plant in India as one of the central figures in the production of blood pressure meds that were found to contain unacceptable levels of NDMA and other suspected carcinogens. The discovery led to the global recall of angiotensin II receptor blockers (ARBs) such as valsartan, losartan and irbesartan.
The FDA said Torrent was one subject of an ongoing global investigation into the production of tainted meds. Since then, the FDA has cited a Mylan plant for many of the same problems.