FDA 483 - IntelliPharmaCeutics Corp. - June 14, 2019
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An FDA inspection of Intellipharmaceutics Corp., a drug manufacturer in Toronto, Ontario, revealed significant deficiencies across multiple systems. Observations included inadequate equipment cleaning and validation, compromised data integrity in laboratory computer systems, and an improperly designed sampling booth. The firm also failed to follow written procedures for complaint investigations and environmental monitoring, and lacked scientifically sound sampling plans and hold time justifications.
ID · 403cc2b4-473f-41ed-aa24-59a66e7b0054