# FDA 483 - BioSculptor Corporation - October 19, 2022

Source: https://www.keypedia.com/records/483/biosculptor-corporation/f4530652-00a0-4ba2-bc62-9e714b26a9c5

> FDA 483 for BioSculptor Corporation on October 19, 2022. Product: devices. 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: devices
- Office Name: Florida District Office
- Summary: BioSculptor Corporation, a medical device manufacturer, underwent an FDA inspection from October 17-19, 2022. The inspection resulted in a Form FDA 483, citing four significant observations regarding their quality system, particularly concerning the manufacturing of their kinderBAND
TM plastic pediatric cranial orthosis helmet. A key issue, noted as a repeat observation, was inadequate procedures for equipment calibration, specifically failing to record identification and certification status for reference equipment used in in-house calibrations of thermostats and thermometers. Additionally, device history records were not adequately maintained, with final in-tolerance temperatures for helmets not being recorded when initial manufacturing temperatures fell outside specified ranges, contrary to their own procedures. Further observations included insufficient procedures for supplier management, lacking clear definitions for new vendor approval processes and ongoing monitoring activities. Finally, and also a repeat observation, the company's internal quality audit procedures were deemed inadequate, as audits were conducted by personnel without appropriate training to ensure compliance with established quality system requirements. BioSculptor Corporation committed to correcting these identified deficiencies.

## Related Documents

- [483 - 2020-03-13](https://www.keypedia.com/records/483/biosculptor-corporation/948ee89b-222a-4fa6-95fc-bbed8d400db4)
- [483 - 2022-10-19](https://www.keypedia.com/records/483/biosculptor-corporation/b3c36059-2dd7-4e11-b9bb-7f76d9d8446d)

## Related Officers

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

Company: https://www.keypedia.com/companies/biosculptor-corporation/f6ac4ae6-7658-4011-b39e-b2241b1e58aa

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9