# FDA 483 - Sarasota Medical Products, Inc. - June 12, 2019

Source: https://www.globalkeysolutions.net/records/483/sarasota-medical-products-inc/4b12fb93-fdde-4a8e-9a93-2b1ee6827eec

> FDA 483 for Sarasota Medical Products, Inc. on June 12, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sarasota Medical Products, Inc.
- Inspection Date: 2019-06-12
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Sarasota Medical Products Inc, a medical device manufacturer in Sarasota, FL, was inspected by the FDA. The inspection revealed significant deficiencies in process validation for sterilization, particularly for HTLA Hydrocolloid adhesive products, as well as inadequate procedures for Medical Device Reporting (MDR). Additionally, device history records were found to be incomplete, indicating a lack of adherence to quality system requirements.

## Related Officers

- [Joshua J. Silvestri](https://www.globalkeysolutions.net/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.globalkeysolutions.net/companies/sarasota-medical-products-inc/ca0b601d-21c3-458c-b0b7-ff0f55241a55

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