The QMN Weekly Bulletin
Pharmaceuticals / Inspections and Audits

FDA Blows the Whistle on UMich for Unsterile Conduct

Oct. 20, 2017
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The University of Michigan Medical Center processed and compounded drugs under unsanitary conditions, the FDA said in a warning letter.

Workers rested their gloved hands and gown sleeves on work surfaces in a sterile working area and used non-sterile wipes for cleaning ventilation hoods, the letter said in reporting results of a June 2016 inspection. One cleanroom contained hard-to-clean items such as chairs, computers and damaged floor seams and ceiling tiles.

The center’s response to the findings lacked detail, the letter said. For example, the center reported repairs to floors and ceilings but did not provide supporting documentation, the FDA said.

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