# FDA 483 - ID Biomedical Corporation of Quebec - May 20, 2022

Source: https://www.globalkeysolutions.net/records/483/id-biomedical-corporation-of-quebec/a99c9856-111a-4c5e-849a-a5f1e2fa7957

> FDA 483 for ID Biomedical Corporation of Quebec on May 20, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ID Biomedical Corporation of Quebec
- Inspection Date: 2022-05-20
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: ID Biomedical Corporation of Quebec, a licensed biological drug manufacturer, was inspected by the FDA from May 12-20, 2022. The inspection revealed significant deficiencies in quality control, complaint handling, aseptic processing, and preventative maintenance. Issues included inadequate investigations into missing data, incomplete complaint records, and procedures insufficient to prevent microbial contamination of sterile drug products.

## Related Documents

- [483 - 2022-05-20](https://www.globalkeysolutions.net/records/483/id-biomedical-corporation-of-quebec/9967e4d8-c4cd-4617-b4ce-17fce8884920)

## Related Officers

- [Team Biologics Staff](https://www.globalkeysolutions.net/people/linda-thai/f4d9a1c3-e5e8-4f13-8abe-e1f1e597c8f8)
- [Strategic Expert at NovoNordisk; Retired from FDA](https://www.globalkeysolutions.net/people/debra-m-emerson/58bd7fac-28eb-4369-b149-13a24cc00cf7)

Company: https://www.globalkeysolutions.net/companies/id-biomedical-corporation-of-quebec/027ba99e-0b4d-49dc-afc6-4104513a656f

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