SalemNews.com, Salem, MA

Nation/World

October 27, 2012

FDA: Mold, bacteria at pharmacy tied to outbreak

WASHINGTON (AP) — Federal health inspectors say staffers at a pharmacy linked to the meningitis outbreak over the past year documented dozens of cases of mold and bacteria growing in rooms that were supposed to be sterile.

The Food and Drug Administration inspectors said that even though the mold and bacterial contamination at the Massachusetts pharmacy exceeded the company’s own safety levels, there is no evidence that the pharmacy investigated or corrected the problem.

The FDA released its preliminary report on conditions at the New England Compounding Center in after inspecting the company earlier this month.

Federal inspectors found a host of potential contaminants in or around rooms that were supposed to be kept sterile, including green and yellow discoloration, water droplets and standing water from a leaking boiler. Many of the findings echo observations reported by state inspectors earlier this week.

Steroid injections made by the New England Compounding Center have been tied to an outbreak of fungal meningitis that has sickened 338 people across the U.S., causing 25 deaths. Last week FDA officials confirmed that the black fungus found in company vials is the same as that which has sickened patients.

Compounding pharmacies prepare their medications in clean rooms, which are supposed to be temperature-controlled and air-filtered to maintain sterility. But FDA inspectors noted that workers at the pharmacy turned off the room’s air conditioning every night.

1
Text Only | Photo Reprints
Nation/World

Local News
  • Coast Guard searching for missing diver off Marblehead

    The U.S. Coast Guard is searching for a 56-year-old scuba diver who has been reported missing off Children's Island in Marblehead.

    A Coast Guard spokesman said the male diver was reported as "overdue" at 11 a.m. on Tuesday. The man's boat is moored off Children's Island.

    July 22, 2014

  • 140721_SN_DLE_MARKETBASKET5 North Shore Market Basket workers, customers remain defiant

    MIDDLETON -- The Market Basket revolt continues, despite the firing of eight insurgent employees. Workers at the Middleton store on Monday were still making clear their position in favor of ousted CEO Arthur T. Demoulas, though in some cases with ca

    July 21, 2014 5 Photos 5 Stories

  • Lindsay Obama denies religious exemption urged by Gordon College president

    WENHAM — The letter that has caused so much controversy for Gordon College has gone unheeded by President Barack Obama.

    July 21, 2014 1 Photo 7 Stories

  • 140721_SN_PBI_MARKETB_090 Thousands rally after 8 Market Basket execs are fired

    TEWKSBURY -- Valerie Edge has never been afraid for her job. Through the death of her father, a near-fatal crash involving her daughter, and her own lengthy illness, the five-year employee of the Epping, N.H., Market Basket said her bosses always tol

    July 22, 2014 4 Photos 1 Slideshow 4 Stories

  • Tobin Bridge toll booths are history BOSTON -- The next time you drive over the Tobin Bridge on Route 1 into Boston, you won't have to fumble for your wallet or root through your purse to pay the toll. On Monday, the state Department of Transportation replaced the toll booths on the upp

    July 22, 2014