# FDA 483 - Creation Technologies Ltd - April 14, 2023

Source: https://www.globalkeysolutions.net/records/483/creation-technologies-ltd/964c7259-13fc-4408-8c8c-5fcf9c6966c9

> FDA 483 for Creation Technologies Ltd on April 14, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Creation Technologies Ltd
- Inspection Date: 2023-04-14
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Creation Technologies Ltd in Burnaby, a contract manufacturer, received a Form FDA 483 with three observations following an inspection from April 10-14, 2023. The observations primarily concern deficiencies in document control, corrective and preventive action (CAPA) procedures, and procedures for ensuring purchased products and services conform to requirements. These issues indicate a need for improved quality system controls.

## Related Documents

- [483 - 2020-03-05](https://www.globalkeysolutions.net/records/483/creation-technologies-ltd/81d485a7-96c6-4ce2-80d7-fdfa053feecd)

## Related Officers

- [Sargum C. Morgan](https://www.globalkeysolutions.net/people/sargum-c-morgan/a769e36a-3382-414a-b9b1-1ebc755c8392)

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

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