# FDA 483 - BioSculptor Corporation - October 19, 2022

Source: https://www.globalkeysolutions.net/records/483/biosculptor-corporation/b3c36059-2dd7-4e11-b9bb-7f76d9d8446d

> FDA 483 for BioSculptor Corporation on October 19, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioSculptor Corporation
- Inspection Date: 2022-10-19
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of BioSculptor Corporation in Hialeah, FL, a medical device manufacturer of the kinderBAND™ cranial orthosis helmet, revealed significant deficiencies in their quality system. The inspection cited repeat observations regarding inadequate equipment calibration procedures and untrained personnel conducting quality audits. Additional issues included failures to maintain device history records and establish adequate supplier management processes.

## Related Documents

- [483 - 2020-03-13](https://www.globalkeysolutions.net/records/483/biosculptor-corporation/948ee89b-222a-4fa6-95fc-bbed8d400db4)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stanley-b-eugene/4708f43e-0592-4c24-b276-d9f9092788a3)

Company: https://www.globalkeysolutions.net/companies/biosculptor-corporation/f6ac4ae6-7658-4011-b39e-b2241b1e58aa

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