# FDA 483 - Creation Technologies LTD - March 09, 2023

Source: https://www.globalkeysolutions.net/records/483/creation-technologies-ltd/d2625414-62be-41e6-bbe4-3efcd33ae6b9

> FDA 483 for Creation Technologies LTD on March 09, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Creation Technologies LTD
- Inspection Date: 2023-03-09
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Creation Technologies LTD in Mississauga revealed significant deficiencies across multiple quality system areas. The firm failed to adequately establish and follow procedures for corrective and preventive actions, control of nonconforming products, change management, and complaint handling. Additionally, software used in production for device label printing was found to be unvalidated.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.globalkeysolutions.net/companies/creation-technologies-ltd/a9ed546a-1989-4184-9d24-ec2d9995b31d

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