The New England Compounding Center (NECC) facility has problems maintaining its clean rooms, the Food and Drug Administration (FDA) informed as it released a copy of the FDA Form 483 to the NECC.
The FDA says it listed a number of “observations”, including contaminated products.
FDA inspectors visited NECC for a total of seven days from October 1st to 26th after the company had recalled a steroid medication.
The clean room is an enclosed space that is supposed to contain a controlled environment with minimum levels of airborne particles and surface contaminants. When sterile drug products are produced, it has to be done in an extremely clean room so that there is no microbial contamination during processing. Processing in the clean room goes all the way to filling the drug into its final container.
The Agency says it found mold inside the NECC, which was visible to the naked eye. Inspectors found 83 vials from one lot of the contaminated steroid that contained “greenish black foreign matter.”
In a bin of 321 vials of methylprednisolone acetate, inspectors found white fibers floating in them. Some vials from this lot had already been sent out to health care providers throughout the USA.
After the FDA carries out an inspection, and the investigators believe that conditions and practices might violate the Federal Food, Drug and Cosmetic Act, or related regulations, it issues a FDA Form 483.
The FDA emphasizes that the 483, in itself, is not an FDA conclusion that anything that is listed in the document is a violation of the Act or any related regulations.
After the 483 has been released, the FDA:
- Considers the observations in the 483
- Considers an Establishment Inspection Report (EIR) which the FDA investigators have prepared
- Considers responses received from the company
- Considers any other relevant information
The FDA added that the inspectors have not yet completed the Establishment Inspection Report, and none of its contents are being shared for the moment.
After taking everything into consideration, the FDA decides whether or not to take any further action.
Several public health authorities are liaising closely regarding this matter, including the FDA, CDC (Centers for Disease Control and Prevention), state partners, and the Massachusetts Board of Registration in Pharmacy.
In the USA at the moment, there is an outbreak of fungal meningitis among patients who took NECC’s compounded preservative-free injectable steroid methylprednisolone acetate (80mg/ml).
A total of 338 people who were administered the contaminated steroid used for the treatment of back pain became infected with fungal meningitis, 25 have lost their lives so far. All the tainted products came from NECC.
Reuters quoted one NECC sales representative who said “I remember thinking, are we just selling too much? Were we growing sales faster than our lab could handle?”
According to accounts by former NECC staff, customers and local press reports, the company grew rapidly, and appears to have taken shortcuts and breached regulations governing compounding practices virtually from day 1. Regulators are being accused of not punishing NECC despite repeated violations of regulations.
On Friday, NECC released the following statement:
“We will review this report and will continue our cooperation with the FDA. We will follow the existing regulatory process and provide our comments to the FDA after we have had adequate time for a complete review of the report.”
Massachusetts Governor, Deval Patrick announced that state authorities will, as from now, carry out annual unannounced inspections of the more than 25 other compounding pharmacies in the state that prepare sterile injectable drugs.
Written by Christian Nordqvist