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•American Regent Inc.•July 26, 2019

FDA 483 - American Regent Inc. - July 26, 2019

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Record Details

American Regent Inc. in Hilliard, OH, a drug manufacturer, was cited for failing to adequately investigate out-of-specification stability results for a distributed drug batch. The inspection also revealed that the firm did not follow its own written production and process control procedures. This included deficiencies in biennial SOP reviews and documentation of cleaning activities in the sterile manufacturing plant.

Company
American Regent Inc.
Inspection Date
July 26, 2019
Product Type
Drugs
Office
Cincinnati District Office
Person
  • Ucheabuchi C. Chudi-nwankwor
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ID · ace94cc9-3260-4e36-ad7d-dafe66ee1c97

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