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Biologic Drug Vials Test Positive for Bacteria


September 07, 2016

The US Food and Drug Administration (FDA) issued a warning letter to Amniotic Therapies of Texas as vials of drugs tested positive for bacteria.

 The agency also noted that it discovered that Amniotic Therapies did not have the proper procedures to prevent such contamination and did not test its products’ sterility.

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Were there adverse events associated with this? Yes. The FDA noted several adverse events, which included two infections that were a result of Mycoplasma hominis.

Earlier, the FDA attempted to have the company shut down, but a federal judge prevented it from doing so. Amniotic Therapies was ordered to “stop manufacturing human cells, tissues or cellular-tissue-based products (HCT/Ps) and recall and destroy all product made since Sept. 11, 2014,” according to a Mass Device report.

The Amniotic Therapies website is currently a single page announcing "scheduled maintenance."

 

--Stephanie Vaccaro

 

References:

1. US Food and Drug Administration. Vials test positive for bacteria; Amniotic censured for sterility controls. FDAnews Drug Daily Bulletin. www.fda.gov. September 7, 2016.

2. Perriello B. Judge blocks FDA’s move to shutter Amniotic Therapies. Mass Device. www.massdevice.com. August 31, 2016.

 

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