FDA Finds Nonsterile Procedures at 30 Compounding Firms

In the wake of last fall's outbreak of contaminated epidural injections, FDA inspectors have sought and found troubling evidence of widespread failure to maintain sterility at compounding pharmacies.

There "continues to be reason for concern" about the sterility of injectable steroids and other supposedly sterile products from compounding pharmacies, according to the Food and Drug Administration (FDA), after inspections at 31 such firms over the past seven weeks. Prompted by the recent outbreak of contaminated steroid injections, the inspections have shown widespread evidence of lax efforts to assure sterility within these facilities.

The recent inspections found "unidentified black particles floating in vials of supposedly sterile medicine; rust and mold in 'clean rooms' where sterile injectable medications were produced; technicians handling supposedly sterile products with bare hands; and employees wearing non-sterile lab coats," FDA Commissioner Margaret Hamburg MD wrote April 11 in the blog FDA Voice.

Six of the firms delayed or attempted to prevent FDA inspectors from entering their facilities, and in two cases (Olympia Compounding Pharmacy of Orlando FL and Wedgewood Pharmacy of Swedesboro NJ) the Agency had to obtain warrants in order to gain access.

Post-inspection reports have been mailed to all of the compounding firms. The complete inspection results for each firm are also available on the FDA website

The FDA plans to take "aggressive action" where it has the authority to do so, and to collaborate with state agencies where it does not.


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