FDA Releases Ameridose Investigation Observations During Fungal Meningitis Outbreak

In the wake of the fungal meningitis outbreak, NECC sister pharmacy Ameridose shut down for FDA investigation on October 10. It recalled all of its products on October 31 and expected to resume business on November 19. But now that the FDA has released its investigation report, that date may be delayed a bit.

As USA Today reported, "Federal drug inspectors found a range of problems, including ineffective drugs given to children and pregnant women, leaky ceilings, insects, non-sterile conditions and at least one bird flying around."

The FDA's 20-page report also detailed the following in its 15 observations:

  • Ameridose failed to test drugs for potency before shipping them, and that the facility received 33 complaints with regard to product ineffectiveness.
  • Ameridose failed to test drugs for sterility and it had been previously been cited for this on August 6, 2008.
  • Ameridose failed to investigate contamination on 53 occasions and it shipped an undisclosed number of products from those contaminated lots. Ameridose also failed to look into what caused the contamination. Further, "There is no documented evidence that your firm implemented permanent corrective actions to prevent these sterility events from recurring," the report stated.
  • Employees' gowns and gloves were not sterile.
  • Ameridose's operating procedures allowed for cross-contamination among products.
  • Ameridose's facility was in a state of disrepair with buckets containing water from leaky ceilings and walls that "were observed to be cracked, corroded, and covered with what appeared to be adhesive material ... where sterile drug products are aseptically prepared."

As for the insects and birds:

  • "Insects were observed to be located in the unclassified area ... where finished sterile product is packaged and stored. The insects were also located within approximately 3-10 ft. of the controlled area where sterile products are manufactured.
  • "At least one (1) bird was observed flying in the unclassified area where sterile finished product is packaged and stored."

Ameridose is preparing a response to the FDA's report, according to Boston.com.

Contact one of our dangerous and defective drug attorneys if you or a loved one suffered fungal meningitis symptoms as a result of NECC's negligence.



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