The FDA has released a copy of its Form 483, which outlines observed conditions at the New England Compounding Center in Framingham, Mass.
The NECC is under investigation for contaminated products that are linked to a meningitis outbreak that has so far killed 23 people. The Form 483 issued to NECC details problems with facility cleanliness and product sterility. Details include:
• Inspectors observed greenish yellow discoloration lining the interior surface of the viewing lens within the inside autoclave.
• Facility records from January 2012 to September 2012 show bacteria isolates in two clean rooms but no documented steps to identify or remove/prevent the contamination.
• Inspectors also observed dark, hair-like discoloration in the gasket and crevices along a wall in one of the clean rooms used to formulate and fill sterile preparations.
The FDA uses the Form 482, establishment inspection report and other relevant information to determine action against NECC. The inspection report has not been completed. Release of the Form 483 follows a state health department report that outlined findings from its own investigation.
Sign up for our FREE E-Weekly for more coverage like this sent to your inbox!
The NECC is under investigation for contaminated products that are linked to a meningitis outbreak that has so far killed 23 people. The Form 483 issued to NECC details problems with facility cleanliness and product sterility. Details include:
• Inspectors observed greenish yellow discoloration lining the interior surface of the viewing lens within the inside autoclave.
• Facility records from January 2012 to September 2012 show bacteria isolates in two clean rooms but no documented steps to identify or remove/prevent the contamination.
• Inspectors also observed dark, hair-like discoloration in the gasket and crevices along a wall in one of the clean rooms used to formulate and fill sterile preparations.
The FDA uses the Form 482, establishment inspection report and other relevant information to determine action against NECC. The inspection report has not been completed. Release of the Form 483 follows a state health department report that outlined findings from its own investigation.
More Articles on Patient Safety:
5 Tips for Infection Control and Quality Improvement
3 Questions to Ask in Order to Create a Culture of Clinical Accountability
Humble Surgical Hospital in Texas Receives Joint Commission Accreditation