# FDA 483 - Creation Technologies Ltd - March 05, 2020

Source: https://www.keypedia.com/records/483/creation-technologies-ltd/81d485a7-96c6-4ce2-80d7-fdfa053feecd

> FDA 483 for Creation Technologies Ltd on March 05, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Creation Technologies Ltd
- Inspection Date: 2020-03-05
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Creation Technologies LP in Burnaby, British Columbia, revealed significant deficiencies in their quality system. The firm's procedures for handling customer complaints, controlling nonconforming product, and implementing corrective and preventive actions were found to be inadequate. Additionally, the company failed to adequately establish procedures for ensuring purchased products and services conform to specified requirements.

## Related Documents

- [483 - 2023-04-14](https://www.keypedia.com/records/483/creation-technologies-ltd/964c7259-13fc-4408-8c8c-5fcf9c6966c9)

## Related Officers

- [investigator](https://www.keypedia.com/people/michelle-j-glembin/e58f4652-d09f-41a7-941d-335c7b5338ad)

Company: https://www.keypedia.com/companies/creation-technologies-ltd/9a085db9-835a-4235-a924-23c49b86db68

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