FDA finds contamination concerns at Ameridose

(AP)—Federal health inspectors have found more than a dozen sterility problems, including insects, at a drugmaking facility with the same founders as the specialty pharmacy linked to a deadly meningitis outbreak.

The has released the results of a monthlong inspection of Ameridose, a Westborough, Mass.-based company that makes a variety of injectable drugs.

Inspectors say they found insects within 10 feet of a supposedly sterile area where drugs are manufactured. In another case, inspectors reported a bird flying into a room where drugs are stored.

Ameridose agreed to shut down for inspection in October after tainted steroids from its sister company, the New England Compounding Center, were linked to a fungal that's spread to 19 states and caused 32 deaths.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

2nd firm agrees to temporary shutdown in outbreak

Oct 10, 2012

(AP)—A Massachusetts company run by the same executives who operated a specialty pharmacy linked to a fatal meningitis outbreak has agreed to temporarily shut down for inspection by state and federal regulators.

FDA: Ameridose issues voluntary recall of all products

Nov 02, 2012

(HealthDay)—Ameridose, a Massachusetts-based manufacturer of sterile injectable products and oral syringes, is undergoing a voluntary recall of all unexpired products in circulation, according to an Oct. ...

Mass. shuts down another compounding pharmacy

Oct 29, 2012

(AP)—Massachusetts officials say they have shut down a compounding pharmacy after a surprise inspection prompted by the nationwide meningitis outbreak linked to a different state company.

Steroid pharmacy passed 2011 inspection in Mass.

Oct 23, 2012

(AP)—The Massachusetts pharmacy linked to a meningitis outbreak that has claimed 23 lives around the country was cleared by state regulators following an inspection last year.

Recommended for you

Ebola virus in Africa outbreak is a new strain

1 hour ago

The Ebola virus that has killed scores of people in Guinea this year is a new strain—evidence that the disease did not spread there from outbreaks in some other African nations, scientists report.

Researchers see hospitalization records as additional tool

2 hours ago

Comparing hospitalization records with data reported to local boards of health presents a more accurate way to monitor how well communities track disease outbreaks, according to a paper published April 16 in the journal PLOS ON ...

User comments