# FDA 483 - SRS Medical Systems Inc. - October 11, 2023

Source: https://www.globalkeysolutions.net/records/483/srs-medical-systems-inc/8b9121df-0d9b-420a-b130-6a8a593f1497

> FDA 483 for SRS Medical Systems Inc. on October 11, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SRS Medical Systems Inc.
- Inspection Date: 2023-10-11
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: SRS Medical Systems Inc. in North Billerica, MA, was inspected by the FDA from October 3-11, 2023. The inspection revealed that the firm's complaint handling procedures were inadequate, specifically for "The Spanner Temporary Prostatic Stent." This deficiency led to multiple complaints remaining uninvestigated for several months without proper justification.

## Related Officers

- [Sunita Pandey](https://www.globalkeysolutions.net/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)

Company: https://www.globalkeysolutions.net/companies/srs-medical-systems-inc/6e980d4d-6d65-427c-a20c-d2fd1515e159

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7