# FDA 483 - Diva International Inc. - March 12, 2015

Source: https://www.keypedia.com/records/483/diva-international-inc/04ce869d-22fa-475e-a2fb-78fc6e8b227d

> FDA 483 for Diva International Inc. on March 12, 2015. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Diva International Inc.
- Inspection Date: 2015-03-12
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Diva International Inc., a medical device manufacturer in Kitchener, Canada, received an FDA Form 483 citing multiple quality system deficiencies. The inspection revealed inadequate procedures and records for complaint handling, insufficient documentation of corrective and preventive actions, and a complete lack of written procedures for Medical Device Reporting. These observations highlight significant areas for improvement in the firm's regulatory compliance.

## Related Officers

- [Adaliz Santaliz-Cruz](https://www.keypedia.com/people/adaliz-santaliz-cruz/47bd4220-e6cc-4582-a4f5-bd4337f92622)

Company: https://www.keypedia.com/companies/diva-international-inc/24a28126-4764-4da7-8673-6a7ac6bedd8d

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