FDA Inspectors Find Mess During Audit of TN Pharmacy

FDA Inspectors Find Mess During Audit of TN Pharmacy

June 18th, 2013 // 12:51 pm @

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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The 483 on Main Street Pharmacy shows that many rooms that were supposed to be sterile were not. Product was splattered on many surfaces in these rooms, and many of the cleaning practices were not the right kind to eliminate fungal spores. The company also was determined to conduct its own pest control and there were spiders in one of the clean rooms.

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The 483 also stated that every batch of drug product that is supposed to be sterile was not tested in a laboratory to confirm that it was actually sterile. The report also stated that a motor on one device was leaking oil and there was a paper towel laid down to soak up the oil.

Also, Main Street did not keep samples of products it had shipped, so that it can be tested in case there is a problem down the road. It also lacked complete records of what lot was shipped where. And, there was a complete lack of a quality control unit.

FDA is now requesting from Congress more authority so that it can regulate compounding pharmacies such as Main Street. These types of firms are licensed like a regular pharmacy but in reality operate more as drug manufacturers. Congress is currently working on legislation to give FDA more power in this area.

What do you think? Should Congress provide FDA with the authority to regulate compounding pharmacies?

 


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