FDA Inspection Finds Sterility Breaches at Major Compounding Pharmacy

Inspection reports from the US Food and Drug Administration suggest a major drug compounding pharmacy failed to take steps to ensure the sterility of its products. Image: iStockphoto.com/pagadesign

From filth and a leaky roof in areas intended for the production of sterile drugs to a bird and bugs in areas used to store drugs, inspectors from the US Food and Drug Administration (FDA) found serious failures to ensure drug sterility at Ameridose, a major supplier of compounded drugs to US hospitals.

The report, released Monday afternoon, is the latest in a string of agency actions sparked by a nationwide outbreak of 438 reported fungal meningitis infections, including 32 deaths. The outbreak has been linked to injectable steroids distributed by the New England Compounding Center (NECC) in Framingham, Mass.

Additionally, another new report, from the House Committee on Energy and Commerce, outlines a decade-long history of regulatory violations by NECC.  The committee is holding a hearing on the outbreak Wednesday.

In October, products from the NECC were recalled and production stopped after FDA officials observed fungal contamination in vials of methylprednisolone acetate from the company. As a precaution, FDA inspectors also were sent to Ameridose, a sister company to the NECC located in Westborough, Mass. Preliminary results of the FDA inspection prompted a voluntary recall of Ameridose products on October 31. The agency said it is working to mitigate drug shortages that may be exacerbated by the recall and shut-down at Ameridose.

Now, the report provides details about the conditions at Ameridose. Investigators documented rusty and dirty ventilation hoods, nonsterile gowning of staff, and an actively leaking roof in areas intended for production of sterile drugs. The report also cites a failure to adequately test drugs for potency or sterility at the facility, even after receiving numerous complaints of noneffectiveness of some of its products, including lots of ephedrine, oxytocin, and fentanyl.

The report notes 53 times when the company failed to investigate observed microbial contamination of sterile solutions intended for use in injectable products. The company’s quality unit also failed to evaluate customer complaints about potency and sterility and to appropriately classify reported adverse events involving patients.



Categories: Adverse Effects, Infectious Diseases, Patient Safety/Medical Error, Public Health

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