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.
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.
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
The company late last month issued a voluntary recall of all its unused products.
Paven, spokesman for the company, said Ameridose was preparing a full
response to the U.S. Food and Drug Administration report.
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.
"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.
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.
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.
when Ameridose detected multiple bacteria, the inspection report states
the company failed to fully investigate the underlying cause.
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.
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,
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.
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.
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.
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."