Compounding Facility Responsible for Meningitis Outbreak Knew of Unsanitary Conditions and Failed to Act
- Ennis & Ennis News
10/29/2012 - The compounding lab that is responsible for the recent meningitis outbreak actually knew about the mold and bacterial contamination within its facility and failed to do anything about it. New England Compounding Center’s (NECC) own internal bacterial and mold monitoring program revealed unsanitary conditions dating back to at least February 2012, according to the FDA’s Form 483.
An FDA Form 483 is issued to companies that appear to have “objectionable conditions” that may constitute violation of the Food Drug and Cosmetic Act. According to the 483 Form issued to NECC on October 26, 2012, the inspection of the facility revealed: 1) Eighty-three vials of methylprednisolone acetate that contained a “greenish black foreign matter”; 2) Seventeen vials of methylprednisolone acetate that contained while filamentous material; 3) Evidence that the company shuts off the air conditioning overnight, when in fact, the sterile products are to be stored in air controlled rooms that maintain a certain minimum temperature; and 4) A dark, hair-like discoloration along the gasket and crevices located in a room utilized to fill sterile preparations, amongst other things. More disturbingly, the company’s own monitoring program documented and confirmed the presence of various molds and bacteria located within different rooms every month from February – July 2012. NECC’s egregious act of choosing to “look the other way” and failing to act is currently responsible for 344 cases of meningitis, including 25 deaths.
On September 25, 2012, NECC recalled it product, methylprednisolone acetate, used in steroid injections. The recalled methylprednisolone acetate was a preservative-free product, thereby calling for very strict sanitary conditions, which clearly were not met.
Remember the law limits the time in which a claim can be filed, so don't wait to explore your legal rights.
Free Nationwide Methylprednisolone Acetate Meningitis Lawsuit Case Evaluations
If you or a loved one have been injured or suffered a loss as a result of meningitis induced by tainted steroid injections you may be entitled to compensation. Contact the Methylprednisolone Acetate Meningitis Lawsuit Attorneys of Ennis & Ennis today for a free confidential case evaluation by filling out the form on this page or call toll-free: 1-800-856-6405.
Steroid Injection Meningitis Side Effects Main Page::