# FDA 483 - Craftmatic Industries, Inc. - February 12, 2020

Source: https://www.globalkeysolutions.net/records/483/craftmatic-industries-inc/025386e8-9ff8-4075-939b-df33071d2651

> FDA 483 for Craftmatic Industries, Inc. on February 12, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Craftmatic Industries, Inc.
- Inspection Date: 2020-02-12
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Craftmatic Industries, Inc. in Pompano Beach, FL, a specification developer of adjustable therapeutic beds, received 13 observations during an FDA inspection. The firm failed to report a significant field correction for bed separation issues, inadequately handled and investigated numerous complaints, and demonstrated systemic deficiencies across its quality system, including CAPA, management review, purchasing controls, design controls, quality audits, and personnel training. These issues indicate a severe lack of adherence to regulatory requirements and internal procedures, posing potential risks to device users.

## Related Documents

- [WARNING_LETTER - 2014-08-08](https://www.globalkeysolutions.net/records/warning_letter/craftmatic-industries-inc/ee048cc5-f3cb-457d-b6f0-39c7e2f9aa21)
- [483 - 2022-03-07](https://www.globalkeysolutions.net/records/483/craftmatic-industries-inc/960f7595-6548-450d-8f70-f66bbcdb41d0)

## Related Officers

- [Ashley A. Mutawakkil](https://www.globalkeysolutions.net/people/ashley-a-mutawakkil/512be391-fd96-451c-9569-98e43cfba9db)

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

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