FDA Finds Contamination Issues At Ameridose In Westborough
WESTBOROUGH (CBS) – The FDA has found widespread problems at Ameridose in Westborough, the sister company of the compounding center at the heart of the meningitis outbreak that has killed 31 people.
The FDA’s month long inspection found problems ranging from mold and bacteria found in areas where sterile products are made, as well as what appeared to be thick residues that were orange, brown and green in color. The report shows insects and a bird were found in the area where they stored packaged products.
READ: FDA Report
The report cited failure to test drugs for sterility, failure to test products for potency, failure to investigate complaints, and failure maintain equipment and facilities.
It also detailed complaints from patients, including specific problems reported after using a drug used during child birth.
We showed the report to Todd Brown, the Vice Chair of the Department of Pharmacy at Northeastern University. Brown says, “The failure to correctly test the sterility of products that were made and the number of complaints received about products made by Ameridose is very disturbing.”
Brown says, “The number and scope of the deficiencies included in the inspection indicate significant and widespread problems. The structural problems with the building and equipment are significant and correction of these problems will take a significant amount of time.”
Brown also asks, “The results of the inspection leave me wondering why the FDA did not inspect Ameridose sooner or why these problems were not caught on previous inspections?”
No infections have been linked to Ameridose. They voluntarily shut down last month, and laid off hundreds of workers last week.
Ameridose released the following statement:
“We have received the FDA’s written observations included in their Form 483 that is based on a comprehensive 30-day review of our facilities and our processes, conducted by more than 20 inspectors representing both state and federal agencies. While Ameridose’s history shows clearly that we have not had any instance of contaminated products over the course of the past six years, which covers the manufacture and shipment of 70 million units of product, and have always been guided by Good Manufacturing Practices (GMP) referenced in federal regulations, Ameridose is committed to addressing all observations in order to enhance our existing systems. We are in the process of preparing a full response for presentation to the FDA.”