NECC couldn’t catch a break last week as the Massachusetts Department of Public Health released its lengthy investigation report of the facility and the FDA followed suit on Friday by releasing details of its own inspection.
The FDA’s eight-page “483 Form” essentially reiterated what DPH found but elaborated like a creative writing student who’s learned the importance of showing rather than telling. Details included:
- “Greenish black foreign matter” in 83 vials of the preservative-free epidural steroid that started the 2012 fungal meningitis outbreak
- Another 17 vials containing “white filamentous material”
- “[G]reenish yellow discoloration,” “tarnished discoloration,” “dark particulate” and “white, filamentous substances” lining and covering surfaces where sterilization was to take place
- A “brown and soiled” tacky mat, which is meant to catch dirt and dust from shoes and cart wheels as a pharmacist or technician enters a clean room, according to modularcleanrooms.com
- A clean room harboring “reddish-brown and cloudy substances”
- And a floor “soiled with thick white debris and thick black, granular material” surrounding a leaking boiler.
NECC’s own clean room records noted the presence of bacteria and mold throughout the year. Personnel allegedly told the FDA that the air conditioner was shut off from 8 p.m. to 5:30 a.m.
The FDA inspected NECC on October 1, 2, 4, 5, 9, 15, and 26. Its website stated that the agency discusses its 483 findings with company management once the inspection has been completed.
“Each observation is read and discussed so that there is a full understanding of what the observations are and what they mean,” the site said.
What NECC owner Barry J. Cadden said in response to those findings has not been reported.