Overview: An investigation by the U.S. Food and Drug Administration (FDA) has revealed a number of safety issues at Ameridose, a drug supplier with ties to the company who caused a nationwide fungal meningitis outbreak due to tainted steroid injections. Following the federal investigation, the FDA has cast doubt on the safety and sterility of the company’s products.
- FDA investigation finds unsanitary conditions at Ameridose, drug solutions were contaminated with germs and rust while birds and insects were flying around areas with sterile products
- The FDA also says the Ameridose failed to investigate patients reports of serious complications linked to their drugs
- Ameridose shares owners with the New England Compounding Center (NECC), who manufactured the tainted steroid injections that caused a deadly fungal meningitis outbreak
Safety Issues at Ameridose
On Monday, the FDA issued a report detailing unsafe practices at Ameridose. According to the New York Times, investigators found drug solutions tainted with germs as well as rusted and unsanitary equipment. The report also detailed a bird and insects flying around in area meant for the packaging and storage of sterile products. Not only were facility conditions a hazard to patient safety, but inspectors also said that Ameridose did not “adequately investigate” serious complications among consumers who used their products.
FDA spokeswoman Sarah Clark-Lynn told NYT, “F.D.A. inspectors observed conditions and practices at Ameridose which demonstrated that the firm could not consistently assure that their injectable products were sterile and safe for use by patients,” Although Ameridose has not been tied to any infections, all of its products have been recalled and its operations have been shut down since early October.
Sister Company to NECC
The New York Times reports that Ameridose was founded by the same people who owned the New England Compounding Center (NECC), the company who made steroid injections tainted a contaminant that caused a recent fungal meningitis outbreak. The owners include Barry Cadden, the chief pharmacist at NECC who has lost his license, businessman Gregory Conigliaro and his sister-in-law Carla Conigliaro. So far, the outbreak has killed 32 people and caused 400 other cases of illness.