# FDA 483 - Bionik, Inc. - February 10, 2020

Source: https://www.keypedia.com/records/483/bionik-inc/292270fd-dfb3-4a18-8560-45925959e2fd

> FDA 483 for Bionik, Inc. on February 10, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bionik, Inc.
- Inspection Date: 2020-02-10
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Bionik, Inc. in Watertown, MA, a manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, with numerous incomplete CAPA files. Additionally, procedures for receiving, reviewing, and evaluating complaints were not properly established, leading to issues with CAPA justifications and inconsistent complaint processing.

## Related Officers

- [Investigator](https://www.keypedia.com/people/allison-a-rodriguez/4298721f-e09d-4881-8e90-3277ceb17e7d)
- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/bionik-inc/ffa246f2-6f42-424a-bd98-18179f15e0ba

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94