FDA finds pharmacy failed to maintain 'clean rooms' as cases rise in meningitis outbreak

Health officials and doctors have tracked down most of the
14,000 people potentially at risk for fungal meningitis, blamed for the
deaths of 25 people and sickening 338 — but the outbreak is still posing
challenges.

In addition to the new numbers released by the Centers for Disease
Control and Prevention (CDC), the Food and Drug Administration released
Friday a copy of the Form 483, which was issued to the New England
Compounding Center (NECC).

The agency issues a Form 483 at the end of an inspection when
investigators believe they may have observed conditions or practices in
violation of the Federal Food, Drug, and Cosmetic Act, or other related
regulations.

In the report, the agency confirmed contaminated products and listed a
number of observations in reference to one of the compounding
pharmacies ‘clean rooms' – a sterile space where medications are
processed and filled into their final containers.

Investigators said they found bacteria and mold on clean room
surfaces. They also found that the NECC had been turning off the air
conditioner in the clean room overnight, which is apparently contrary to
standard climate control procedures for this type of sensitive area.

Facilities are supposed to maintain strict control of humidity, temperature and cleaning in these rooms.

"One observation was the air conditioning in clean room number one
was turned off from 8 p.m. to 5:30 a.m. nightly," said Steven Lynn,
director of the FDA's Office of Manufacturing and Product Quality.
"Next, the investigators reported that the firm's own environmental
monitoring revealed bacteria and mold in multiple locations, including
surfaces in their clean rooms, between January and September 2012."

Investigators didn't need a microscope to see contamination inside
sealed vials of medication of the steroid methylprednisolone acetate,
according to the report.

"It had a greenish-black foreign material and a white filamentous
material inside," Lynn said."Microscopic examination of these vials
showed the presence of fungus."
Lynn added that investigators also observed leaking boilers and standing
water approximately 30 feet from the entrance to the preparation room.

"This room is used to prepare equipment to make the injectable drugs in the clean room," he said.
FDA officials cautioned that a Form 483 does not have legal force, nor
is it a final FDA determination of violations. They added their
investigation of the NECC is still ongoing.

Massachusetts health regulators said earlier this week that they had
turned up evidence of problematic procedures, record-keeping and work
conditions inside the pharmacy facility.

Reuters and Fox News' Jonathan Serrie contributed to this article.

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