Tuesday, June 18, 2013

FDA Inspectors Find Mess During Audit of TN Pharmacy June 18th, 2013 // 12:51 pm @ jmpickett Latest FDA and cGMP Compliance News


A pharmacy in Tennessee is thought to be the main source of another outbreak of fungal infections, and FDA found the pharmacy in disorder during an audit in May.It found, for example, spiders in the clean room and there were no written procedures to assure that the products were sterile.
FDA found bacteria and fungus in several vials of steroid that was distributed by Main Street Pharmacy, based in Newbern, TN. At this time, 25 patients have gotten abscesses after being injected with the product.
Last week, FDA released the 483 report from the inspection of the pharmacy. It found unsanitary conditions similar to what was found at the New England Compounding Center. The steroid shots from that company have been blamed for a serious outbreak of fungal meningitis, killing 58 people.
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