U.S. health inspectors found bugs, a flying bird and other unsterile
conditions at Ameridose LLC, an affiliate of the Massachusetts compounding
pharmacy at the heart of the deadly meningitis outbreak. Westborough, Massachusetts-based Ameridose was closed on October 10 to
allow state and federal investigators to inspect its facilities. On Monday the
U.S. Food and Drug Administration released the results of its investigation.
A sign for pharmaceutical compounding company NECC, a producer of the steroid methylprednisolone acetate, is seen in Framingham, Massachusetts (Jessica Rinaldi Reuters, Reuters / October 8, 2012)
The agency's report details a list of quality control failures at Ameridose,
including a failure to test the potency of its products, a failure to properly
classify patient complaints and the use of "vague, canned language"
when describing negative patient reactions to its drugs. The company, an
affiliate of the New England Compounding Center, said it is in the process of
preparing a full response to the FDA. "Ameridose's history shows clearly
that we have not had any instance of contaminated products over the course of
the past six years, which covers the manufacture and shipment of 70 million
units of product," the company said in a statement. "Ameridose is
committed to addressing all observations in order to enhance our existing
systems."
The investigation of Ameridose follows the closure of the NECC, which
distributed thousands of vials of a steroid linked to an outbreak of fungal
meningitis that has hit 19 states and claimed 32 lives. Inspectors found that
Ameridose failed to investigate customer complaints related to drug potency,
under-filled products and syringe volumes. It also failed to classify
"patient response" complaints as "adverse events."
Several such complains referred to the drug oxytocin, used to induce
labor in childbirth. One referred to "fetal distress and hyper stimulated
uterus." Another customer called to report an increase in post-partum
hemorrhaging. Another reported that a patient had shortness of breath and that
"the throat was closing."
A complaint related to the painkiller fentanyl noted that the patient
was "oversedated" and "unresponsive." Another patient given
the blood-thinner heparin experienced a "life-threatening" negative
reaction.
Inspectors said buildings used to make, process, pack and hold the drugs
were not maintained in a good state of repair. The firm failed to perform a
microbiological assessment after "penetrating leaks" were found in a
building and water dripping above the clean room. "During the inspection
we observed totes placed in the location of the penetrating leaks containing
water," the inspection report noted. "There is no documented evidence
that the leaks were permanently corrected."
Walls were cracked, corroded and covered with what appeared to be
adhesive material in a room where sterile drugs are prepared, the report noted.
Equipment and utensils were not cleaned or sanitized at appropriate intervals
to prevent contamination that could alter the safety, identity, quality or
purity of the drugs, according to the report.
Certain metal surfaces "were observed to contain what appeared to
be brownish structures, atypical in shape," the report noted. Moreover,
the buildings used "are not free of infestation by rodents, birds, insects
and other vermin," the report said. Specifically, insects were located in
an area where finished sterile product is packaged and stored. The insects were
also located within three to 10 feet of the controlled area where sterile
products are manufactured. At least one bird was observed flying in an area
where sterile finished product is packaged and stored.
On Friday, Ameridose, which has the same owners as NECC, said it would
lay off about 90 percent of its work force. About 650 employees at Ameridose
will be affected, as well as 140 employees at Medical Sales Management, a
company that provides sales, technology and human resources support to
Ameridose.
Source: Chicago Tribune
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