The U.S. Food and Drug Administration says that 30 pharmacies were found to have potential safety issues after the agency started inspections following a meningitis outbreak that stemmed from contaminated drugs.
Thirty-one compounding pharmacies that produce sterile drugs were targeted by FDA inspectors, according to the agency. Sterile products are cause for concern because they must be made under extremely sanitary conditions.
And all except one pharmacy were issued safety reports that outline various health risks, including the existence of dust and mold in what are supposed to be sterile rooms, ventilation issues and problems with employees not wearing the proper non-sterile laboratory coats.
The agency's inspectors visited pharmacies in 18 states, including Florida, Arizona, Colorado, Tennessee and New Jersey.
The inspections come after a fatal fungal meningitis outbreak, associated with contaminated steroid injections from the New England Compounding Center in Massachusetts, was discovered.
Fifty-three deaths and 733 illnesses resulted from the outbreak that was first identified this past September.
And FDA officials say that while regulatory and surveillance efforts have been increased since the meningitis outbreak occurred, they experience various obstacles due to the conflict between state and federal regulations.
FDA Commissioner Margaret Hamburg said that four pharmacies did not even let inspectors enter their premises, according to a blog post on the agency's site. And even more, search warrants and U.S. marshals had to get involved when inspectors tried to enter two pharmacies.
"These challenges and other highlight the need for clearer authorities for FDA to efficiently protect public health," Hamburg wrote.
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