An inspection by the U.S. FDA has found leaking ceilings and insects inside a pharma facility used for the manufacture of medicines.
The Federal health inspectors were undertaking a routine examination of the pharma company Ameridose when they discovered more than a dozen manufacturing problems, including leaky ceilings and insects, according to the Wall Street Journal. The company makes drugs that are administered by injection designed to treat pain relief and for anesthetic injections.
Ameridose is located in Westborough, Massachusetts. The company is linked to the NECC facility linked to a fungal meningitis scandal which has killed over thirty people to date (a story covered in-depth on the Digital Journal).
The U.S. Food and Drug Administration (FDA) found insects located close to the area where the drugs are prepared in an aseptic manner. In another incident, the FDA found a bird flying into a room where drugs are stored.
Other areas of concern included leaks and cracks in the ceiling and walls of a cleanroom. Much of the equipment appeared rusty.
The FDA also raised concerns that over fifty incidents of bacterial contamination had not been investigated thoroughly. The agency was particularly concerned that the company had not put effective corrective actions in place, designed to prevent re-occurrence of the contamination.
Ameridose’s director of human resources, Geri Weinstein is quoted by White Coats News as saying: " It was the Company’s expectation that the suspension of operations would be temporary in nature and that we would be able to fully resume operations in a short time period. While we continue to expect to resume operations, we have now determined that because of the continued inspection by state and federal authorities it may be necessary to resume operations at a reduced level."
The drugs, which are on the FDA’s critical shortage list, are commonly used during surgery and to relieve pain. The FDA investigation could lead to a shortage of these drugs in relation to availability to hospitals.
Ameridose and NECC were founded by brothers-in-law Barry Cadden and Greg Conigliaro. Ameridose says it is a separate entity with distinct management. However, the NECC issues and the FDA report into Ameridose raise questions about the controls in place for the manufacture of medicines.