# FDA 483 - Craftmatic Industries, Inc. - March 07, 2022

Source: https://www.keypedia.com/records/483/craftmatic-industries-inc/960f7595-6548-450d-8f70-f66bbcdb41d0

> FDA 483 for Craftmatic Industries, Inc. on March 07, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Craftmatic Industries, Inc.
- Inspection Date: 2022-03-07
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Craftmatic Industries, Inc. received a Form FDA 483 with 14 observations, many of which are repeat observations from a previous inspection. The observations highlight significant deficiencies in the firm's quality system, particularly concerning complaint handling, corrective and preventive actions, design controls, medical device reporting, and supplier management. These issues led to an unreported recall of adjustable beds and ongoing risks of injury to users.

## Related Documents

- [WARNING_LETTER - 2014-08-08](https://www.keypedia.com/records/warning_letter/craftmatic-industries-inc/ee048cc5-f3cb-457d-b6f0-39c7e2f9aa21)
- [483 - 2020-02-12](https://www.keypedia.com/records/483/craftmatic-industries-inc/025386e8-9ff8-4075-939b-df33071d2651)

## Related Officers

- [David M. Wilkinson](https://www.keypedia.com/people/david-m-wilkinson/5e81ba03-7602-46d6-b675-26efc77d28db)

Company: https://www.keypedia.com/companies/craftmatic-industries-inc/31a9cc4c-5db6-421c-9fc7-a44c6bf8e736

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6