Clinical Notes: FDA Turns Up Heat On Compounders

By John Greer, Deputy Managing Editor, Medpage Today/April 14, 2013

FDA inspectors found all but one of 29 compounding pharmacies making sterile products to be violating federal standards. 

FDA Finds Fault With 28 Compounding Pharmacies

FDA inspectors issued violation notices to 28 compounding pharmacies after surprise inspections – that is, nearly every pharmacy they visited that was producing supposedly sterile drugs. 

Among the deficiencies:

“Unidentified black particles floating in vials of supposedly sterile medicine.”

Mold in clean rooms.

Workers handling sterile products with their bare hands and wearing nonsterile lab coats.

Following the inspections, several of the pharmacies issued voluntary recalls and others stopped production in order to correct problems, according to FDA Commissioner Margaret Hamburg, MD. 

For full story, see Medpage Today’s website. 

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