483
Creative Testing SolutionsFDA 483 - Creative Testing Solutions - July 16, 2019
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An FDA inspection of Creative Testing Solutions, a testing laboratory in Charlotte, revealed two significant observations. The firm failed to maintain adequate processing records, specifically lacking documented investigations for invalidated test results. Additionally, blood and blood components were not tested for transfusion-transmitted infections according to manufacturer instructions, leading to invalidated reactive and indeterminate test results.
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ID · 401b4859-ea14-4929-91e1-e6e8c402ee20