# FDA 483 - Abbott Point of Care Canada Limited - May 16, 2022

Source: https://www.globalkeysolutions.net/records/483/abbott-point-of-care-canada-limited/92a2976e-a39c-4d5e-b5da-71581bf21ec2

> FDA 483 for Abbott Point of Care Canada Limited on May 16, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbott Point of Care Canada Limited
- Inspection Date: 2022-05-16
- Product Type: other
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Abbott Point of Care Canada Limited, a contract manufacturer in Nepean, Ontario, Canada, identified deficiencies related to design controls and production and processing. The observations included issues with creating and approving master records, general design controls, device specifications, and managing production and processing changes. These findings indicate a need for improved adherence to quality system requirements for medical device manufacturing.

## Related Documents

- [WARNING_LETTER - 2022-05-19](https://www.globalkeysolutions.net/records/warning_letter/abbott-point-of-care-canada-limited/7b8c8900-28e8-43f0-835e-9aada047b889)

## Related Officers

- [Sean T. Creighton](https://www.globalkeysolutions.net/people/sean-t-creighton/80ffecab-0a2d-4727-a11f-407b697f4503)

Company: https://www.globalkeysolutions.net/companies/abbott-point-of-care-canada-limited/cd452e71-30d5-4307-a3ed-1cf00f2360a3

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