FDA 483 - Resilience Biotechnologies, Inc. - February 07, 2020

Therapure Biopharma, Inc., a contract drug substance manufacturer in Mississauga, Ontario, was inspected and cited for significant deficiencies across its quality system. Observations included a deficient Quality Assurance unit with ineffective CAPAs and inadequate oversight, failure to follow written procedures for environmental monitoring investigations, inadequate cleaning validation, and a lack of thorough investigation into recurring process discrepancies and unvalidated process changes. These issues indicate systemic weaknesses in maintaining a state of control and ensuring product quality.