Investigators found insects, rodents, and a bird at a company linked to the Massachusetts pharmacy at the center of the multistate outbreak of fungal meningitis that killed 32 people and sickened hundreds, highlighting potential sterility problems at the facility.
The U.S. Food and Drug Administration (FDA) Monday noted in its inspection report a number of violations at facilities owned by Ameridose, a sister company to the New England Compounding Center, which allegedly issued injections that were contaminated.
“Insects were observed to be located in the unclassified area … where finished sterile product is packaged and stored,” the report stated. There were insects within several feet “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,” continued the report.
The FDA said that there was at least 53 times when Ameridose failed to investigate microbiological contamination during sterility testing to make injections.
Ameridose in late October issued a recall of all its products in relation to the contamination.
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