FDA report says pharmacy knew about contamination problems

Oct 29 2012

The New York Times: F.D.A. Details Contamination at Pharmacy
A federal inspection of a company whose tainted pain medicine has caused one of the worst public health drug disasters since the 1930s found greenish-yellow residue on sterilization equipment, surfaces coated with levels of mold and bacteria that exceeded the company's own environmental limits, and an air-conditioner that was shut off nightly despite the importance of controlling temperature and humidity. The findings, made public on Friday by the Food and Drug Administration, followed a report from Massachusetts regulators on Tuesday and offered disturbing new details in an emerging portrait of what went wrong inside the New England Compounding Center, the pharmacy at the heart of a national meningitis outbreak in which 25 people have died, 313 more have fallen ill and as many as 14,000 people are believed to have been exposed (Tavernise and Pollack, 10/26).

The Washington Post: Compounding Pharmacy Linked To Meningitis Outbreak Knew Of Mold, Bacteria Contamination
The Massachusetts specialty pharmacy linked to the deadly fungal meningitis outbreak knew it had extensive contamination by mold and bacteria throughout its operations for making sterile drugs but failed to take corrective action, federal health officials said Friday. In the first nine months of the year, New England Compounding Center's internal monitoring program showed mold or bacterial contamination at more than 80 locations, including numerous places in its "clean rooms" where sterile drugs are made (Sun, 10/26).

The Wall Street Journal: Pharmacy Faulted Further By FDA
The FDA said the pharmacy director of NECC, based in Framingham, Mass., told federal inspectors that the firm used non-sterile active pharmaceutical ingredients and raw materials, with the exception of sterilized water for injection, to make the injectable steroid linked to the fungal meningitis. ... NECC said in a statement Friday that it is cooperating with the FDA, had just received a copy of the report and plans to "provide our comments to the FDA after we have had adequate time for a complete review of the report." ... Steven Lynn of the FDA's center for drug evaluation and research said that the use of non-sterile material to make such products isn't necessarily unsafe if it becomes sterilized at some point in the process (Burton and Rockoff, 10/26). 

NPR: FDA Says Massachusetts Pharmacy Knew Of Sterility Problems For Months
In a highly unusual step, the Food and Drug Administration has released a report of inspections it conduct this month of the Massachusetts pharmacy at the center of a national outbreak of fungal infections. FDA officials say the New England Compounding Center's own environmental monitoring showed multiple instances of bacterial and fungal contamination of two "clean rooms" going back nearly nine months before an outbreak of meningitis linked to one the company's drugs (Knox, 10/26).