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

Source: https://www.globalkeysolutions.net/records/483/resilience-biotechnologies-inc/04d1400f-cb6c-438c-9014-f6572907bc70

> FDA 483 for Resilience Biotechnologies, Inc. on February 07, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Resilience Biotechnologies, Inc.
- Inspection Date: 2020-02-07
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Jie He](https://www.globalkeysolutions.net/people/jie-he/162aef4b-4b22-48e5-9a50-9b2e9684d589)
- [Strategic Expert at NovoNordisk; Retired from FDA](https://www.globalkeysolutions.net/people/debra-m-emerson/58bd7fac-28eb-4369-b149-13a24cc00cf7)
- [Eileen A. Liu](https://www.globalkeysolutions.net/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

Company: https://www.globalkeysolutions.net/companies/resilience-biotechnologies-inc/b3d6ed53-42d5-4c02-adca-c777bb39151c

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd