# FDA 483 - BioSculptor Corporation - March 13, 2020

Source: https://www.globalkeysolutions.net/records/483/biosculptor-corporation/948ee89b-222a-4fa6-95fc-bbed8d400db4

> FDA 483 for BioSculptor Corporation on March 13, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioSculptor Corporation
- Inspection Date: 2020-03-13
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: BioSculptor Corporation, a medical device manufacturer in Hialeah, FL, was cited for multiple significant deficiencies during an FDA inspection. The observations primarily concern inadequate quality system procedures related to production process control, complaint handling, incoming product acceptance, labeling, equipment calibration, and internal quality audits. These issues indicate a systemic lack of control over critical manufacturing and quality assurance activities.

## Related Documents

- [483 - 2022-10-19](https://www.globalkeysolutions.net/records/483/biosculptor-corporation/b3c36059-2dd7-4e11-b9bb-7f76d9d8446d)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

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