麻豆传媒

The New England Compounding Center (NECC) at the center of the deadly fungal meningitis outbreak found numerous instances of bacteria and mold growing in rooms meant to produce sterile products months before the current outbreak, on Friday showed.

Despite those findings by its own workers, the NECC documented no corrective action to prevent contamination of its sterile drug products, the FDA said following its most recent inspection this month.

Instead, the Massachusetts-based NECC continued to produce products in the "clean rooms" before the nationwide outbreak started earlier this month. Sterile products should be produced in sterile rooms to reduce the risk of contamination.

Also on Friday, the of the fungal meningitis with an additional death in Tennessee, bringing the total number of deaths to 25. There are now 331 fungal meningitis cases in 18 states with seven peripheral joint infections.

In addition to the one death, Tennessee also reported four new cases, bringing its total to 74. Maryland, Michigan, Minnesota, and New Hampshire also reported new cases, the CDC said.

, detailed in what it calls a Form 483, together with information released earlier this week from Massachusetts health officials, paints a picture of a sloppy compounder mass producing drugs under less-than-sterile conditions.

The form lists five pages of instances where the NECC's environmental monitoring found bacteria or mold growing in rooms where sterile drug products were made. The tests appear to have been done weekly and were taken from floors, counters, walls, and hoods in two rooms.

"There were no product impact assessments performed for any sterile products that were made in the hoods or gloveboxes on the days the samples were taken," the form stated.

Such rooms should be cleaned daily depending on the company's production schedule, the FDA told reporters in a conference call. But just because there was no documented action doesn't mean none was taken.

What is known is that a tainted steroid -- preservative-free methylprednisolone acetate -- made by NECC was shipped to pain clinics in 23 states with more than 14,000 patients exposed to the potentially contaminated injection.

The FDA inspection lasted seven days from Oct. 1 to Friday, the form shows.

There were 17 vials of the steroid from a bin of 321 that had "what appeared to be white filamentous material," the form stated. Another 83 contained a "greenish black foreign matter."

In the conference call with reporters Friday afternoon, the FDA declined to answer multiple questions about what the visible matter was, how it got there, or how long it had been in vials.

The report further noted that NECC's autoclave did work properly but showed "tarnished discoloration on the interior surfaces."

There was also a greenish yellow discoloration lining the interior surface of the viewing lens. The autoclave was used to sterilize methylprednisolone.

FDA inspectors also noted that NECC turned off the air conditioning every night, a practice not recommended for sites meant to be kept sterile.

The agency further noted several other findings in the eight-page Form 483:

• A boiler was leaking water into puddles
• The tacky mat located in the transition to the warehouse was "brown and soiled"
• The metal ledge within a room used to formulate and fill sterile preparations had "reddish-brown and cloudy substances"
• Yellow and green residue lining the rear of a hood used to weigh active ingredients and raw materials
• Tarnish on interior surfaces on equipment used to to make sterile products

The form mentions methylprednisolone specifically many times, but NECC made hundreds of other products. So what the FDA released Friday "is not the extent of the entire operation," Howard Sklamberg, FDA deputy associate commission for regulatory affairs, told reporters.

The NECC recalled all of its more than 2,100 products on Oct. 6. The FDA conducted its October investigation with Massachusetts officials, the agency said.

Sklamberg and others on the teleconference with reporters declined to speak about anything outside of the Form 483, citing ongoing state and federal investigations.

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