# FDA 483 - Surgitech Inc - August 10, 2023

Source: https://www.keypedia.com/records/483/surgitech-inc/c99c135a-e6e0-4b6c-aeb3-61579fafa8bf

> FDA 483 for Surgitech Inc on August 10, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Surgitech Inc
- Inspection Date: 2023-08-10
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Surgitech Inc, a specification developer in Carlsbad, CA, was inspected by the FDA from August 8-10, 2023, and received a Form FDA 483 with ten observations. The inspection revealed significant deficiencies across its quality system, including repeat observations related to design control and device history records. The firm demonstrated a systemic lack of adherence to established procedures and regulatory requirements, indicating a severe state of non-compliance.

## Related Officers

- [Ebony D. Sanon](https://www.keypedia.com/people/ebony-d-sanon/703dc125-1019-43d1-9598-1bdc92026e2b)

Company: https://www.keypedia.com/companies/surgitech-inc/2272bfc6-a009-4b35-bdac-84f8c10cb783

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6