Tennessee Compounding Pharmacy Cited for Violations
Posted on Jul 07, 2013
Following New England Compounding Center's national fungal meningitis outbreak from earlier this year, the FDA is saying they have now found bacteria at a Tennessee compounding pharmacy. The Main Street Family Pharmacy was the site of multiple federal regulation violations after inspectors found spiders in the pharmacy's clean room.
The Main Street Family Pharmacy's inspection reports says there were several sterility problems in the clean room and splatter was found on an air filter, trash can, and work surfaces. A worker was also observed preparing sterile products with exposed legs, eye make-up, and studded earrings.
"FDA has identified bacterial and fungal growth in samples from two unopened vials of preservative-free methylprednisolone acetate. The microbial growth was seen in samples from two separate lots," the FDA said in a prepared statement. They also said additional tests are being performed.
The Main Street Family Pharmacy says they are aware of the FDA's notes. "We are working with the FDA and Tennessee Board of Pharmacy to implement new procedures and quality assurance measures to ensure that our products will continue to uphold the highest standards possible for the patients we serve," said Joe Grillo, the pharmacy's spokesman.
As of now, according to the US Centers for Disease Control and Prevention, 26 people in four states have fallen ill because of drugs produced at the Main Street Family Pharmacy. Victims reported infection or inflammation at the site of where they were injected. No deaths have been reported.
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