# FDA 483 - Stingray Surgical Products, LLC - February 09, 2023

Source: https://www.globalkeysolutions.net/records/483/stingray-surgical-products-llc/a3e45c27-d737-4e02-98bb-98ec553e9c42

> FDA 483 for Stingray Surgical Products, LLC on February 09, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stingray Surgical Products, LLC
- Inspection Date: 2023-02-09
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: During an inspection from January 31 to February 9, 2023, Stingray Surgical Products, LLC in Boca Raton, FL, was cited for deficiencies in its quality system. The FDA observed that the firm's procedures for design change were not adequately established, specifically regarding documentation of verification and validation. Additionally, the company failed to adequately establish procedures for corrective and preventive action, as evidenced by not opening a CAPA for a previous FDA inspection observation.

## Related Documents

- [WARNING_LETTER - 2011-12-05](https://www.globalkeysolutions.net/records/warning_letter/stingray-surgical-products-llc/7350435d-e127-470c-9caf-887f4584fc5f)

## Related Officers

- [David M. Wilkinson](https://www.globalkeysolutions.net/people/david-m-wilkinson/5e81ba03-7602-46d6-b675-26efc77d28db)

Company: https://www.globalkeysolutions.net/companies/stingray-surgical-products-llc/543eae0e-7c70-483a-9e4e-01456859071b

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