FDA 483 - CSL Plasma Inc. - March 10, 2022
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CSL Plasma Inc. in Normal, IL, a source plasma center, was cited for three observations during an FDA inspection. The firm failed to adequately investigate a trend of unsuitable donor addresses and did not properly qualify new electronic temperature monitoring systems for plasma storage freezers before use. Additionally, the firm failed to maintain complete temperature records for plasma storage freezers, indicating deficiencies in quality system controls and record-keeping.
ID · 277f40f5-28bc-4094-b12b-d1b128d7ef3c