A Tennessee pharmacy believed to be the source of a second outbreak of fungal infections linked to pain shots was a mess when Food and Drug Administration inspectors went in last month, with stray spiders in a clean room and few written procedures for making sure products were sterile, the FDA says.
The FDA has found fungus and bacteria in at least two vials of steroid distributed by Main Street Pharmacy of Newbern, Tenn. So far, 25 patients in four states have developed abscesses after getting injections of the pharmacy’s product.
On Wednesday, the FDA released the report from an inspection it made at the pharmacy on May 30. It found conditions similar to what the agency has found at several pharmacies that make products to order and distribute them on large scale. Although these so-called compounding pharmacies manufacture large quanties of products, they don’t follow what FDA calls good manufacturing processes.
The result, the FDA says, can be contamination like that traced to the New England Compounding Center, whose steroid shots are blamed for killing as many as 58 people and making 745 sick.
The report on Main Street shows rooms that were supposed to be sterile were not, product was spattered in various places, and cleaning practicies weren’t the right type to kill fungal spores. Even basic hygiene wasn’t there. “Specifically, your firm performs its own pest control and on 5/30/13, two spiders were observed in the ISO 6 clean room,” the report reads.
“Each batch of drug product purporting to be sterile and (contaminant)-free is not laboratory tested to determine conformance to such requirements,” it adds. The motor on one device was leaking oil and a paper towel had been laid down to soak it up.
The firm should have methodically tested products for sterility and potency, but didn’t, the FDA found.
The company doesn’t keep samples of shipped products to test in case there's a problem later, and doesn’t have complete records of what it shipped or where. “There is no quality control unit,” the FDA reports adds.
The FDA has asked for extended power to regulate large pharmacies like Main Street, which are licensed like home town, one-drug-at-a-time pharmacies but which act more like drug manufacturers. FDA commissioner Dr. Margaret Hamburg says another deadly outbreak is certain to come.
Congress is working on a bill to give the FDA these powers.
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