# FDA 483 - Controltek, Inc. - December 20, 2019

Source: https://www.keypedia.com/records/483/controltek-inc/1f34c150-6a84-41cd-bece-3900f17a8e7c

> FDA 483 for Controltek, Inc. on December 20, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Controltek, Inc.
- Inspection Date: 2019-12-20
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Controltek, Inc., a medical device contract manufacturer in Vancouver, WA, from December 16-20, 2019, identified significant deficiencies in their quality system. The firm failed to adequately establish procedures for device history records, corrective and preventive actions, and process controls, indicating a systemic lack of documentation and oversight in critical manufacturing operations.

## Related Officers

- [investigator](https://www.keypedia.com/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)

Company: https://www.keypedia.com/companies/controltek-inc/e10ebf71-31f8-437f-8330-e24838fde527

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822