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Meningitis outbreak: Inspectors find bird flying through Ameridose pharmacy

9:06 PM, Nov 12, 2012   |    comments
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By Walter F. Roche Jr. / The Tennessean 

FDA inspectors found a Massachusetts drug company that has supplied dozens of Tennessee health-care facilities failed to properly test for the sterility of its products and did not investigate multiple complaints, including one case categorized as life-threatening.

The 20-page report on Ameridose LLC issued Monday listed multiple violations of federal regulations. Inspectors even reported seeing a bird flying through a storage area for sterile drugs.

Ameridose, based in Westborough, Mass., has the same owners as the New England Compounding Center, which has been blamed for a nationwide outbreak of fungal meningitis that has killed 31 patients, including 13 in Tennessee.

The company late last month issued a voluntary recall of all its unused products.

Andrew Paven, spokesman for the company, said Ameridose was preparing a full response to the U.S. Food and Drug Administration report.

"While Ameridose's history shows clearly that we have not had any instance of contaminated products over the course of the past six years ... Ameridose is committed to addressing all observations in order to enhance our existing systems," the company's statement said.

The FDA reported that no infections have been linked to Ameridose products.

However, "FDA inspectors observed conditions and practices at Ameridose which demonstrated that the firm could not consistently assure that their injectable products were sterile and safe for use by patients," FDA spokeswoman Sarah Clark-Lynn said in an email response to questions.

"In addition, the firm fails to test finished product for potency, failed to investigate complaints for ineffective products, failed to investigate violations of their own environmental sampling plan, and fails to adequately maintain equipment and facilities used to manufacture sterile drug," she added.

The FDA report detailed repeated instances when Ameridose failed to address complaints.

"Your firm has received approximately 33 complaints claiming lack of effect, patient response events and ineffectiveness for products," the report states, adding that the lots of drugs in question were not tested for potency before release as required.

Other critical findings included:

• Failure to test final units for sterility and the presence of bacterial endotoxins.

• Failure to investigate microbacterial contamination observed at least 53 times.

• Failure to implement corrective action plans to prevent future sterility problems.

• Failure by the firm's quality unit to properly classify patient response complaints as adverse events.

Even when Ameridose detected multiple bacteria, the inspection report states the company failed to fully investigate the underlying cause.

"Despite multiple findings of contaminated units, no attempts were made to subculture the bacteria and further differentiate the microbe to determine its identity," the report states.

Complaints cited by the FDA included reports of fetal distress and postpartum hemorrhaging from an Ameridose drug, oxytocin, used to induce delivery.

In one complaint, the FDA report recounts, the response to an Ameridose blood thinning drug, heparin, was classified as life-threatening. A dose of Fentanyl supplied by the company left a patient "over-sedated, unresponsive."

In other cases, however, complaints showed that Ameridose drugs did not produce the desired or expected results even when the full dosage was administered.

Though Ameridose did do some testing, the FDA found that those efforts were incomplete.

An unexpected result in testing from a lot of morphine doses produced "an unknown peak" that was not investigated "nor has it been evaluated with respect to patient risk." The lots were released anyway.

Other findings include multiple sterility failures in the manufacturing process including improper gowns and gloves used by Ameridose workers handling injectable drugs.

The firm failed to perform microbiological assessment after penetrating leaks were found in the building, the report states, adding that walls were observed to be cracked and corroded in an area where sterile drugs were being prepared. There was no evidence the problems were permanently corrected.

Pieces of equipment, such as hoods used to prepare sterile drugs, "were observed to contain what appeared to be brownish structures, atypical in shape, upon the metal surface."

"Hoods were observed to contain what appeared to be thick residues that were orange, brown and green in coloring," the inspectors found..

Fault was also found with the design and physical structure of the facility including failure to assure sterile processing areas were not cross-contaminated.

"At least one bird was observed flying in the unclassified area were sterile finished product is packaged and stored."

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