# FDA 483 - MedMira Laboratories Inc. - November 18, 2021

Source: https://www.keypedia.com/records/483/medmira-laboratories-inc/022a4b56-6cae-4222-94b7-de387bfc3c92

> FDA 483 for MedMira Laboratories Inc. on November 18, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MedMira Laboratories Inc.
- Inspection Date: 2021-11-18
- Product Type: device
- Office Name: International Compliance Team
- Summary: An FDA inspection of MedMira Laboratories Inc. in Halifax revealed significant issues with medical device reporting and complaint handling. The firm failed to submit timely MDR reports for false positive HIV test results and lacked adequate procedures for evaluating complaints to determine MDR reportability. These deficiencies indicate a serious breakdown in their quality system regarding post-market surveillance.

## Related Officers

- [Ismael Olvera](https://www.keypedia.com/people/ismael-olvera/0fa45168-6e5f-4eb5-9a3d-4ff8992f84d2)
- [Cody D. Rickman](https://www.keypedia.com/people/cody-d-rickman/54deec25-dc65-4402-991a-ad5589bad78b)

Company: https://www.keypedia.com/companies/medmira-laboratories-inc/f0fe31bd-118b-4c1d-8949-ec953f0a031d

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321