# FDA 483 - Asahi Intecc Usa Inc - June 01, 2023

Source: https://www.keypedia.com/records/483/asahi-intecc-usa-inc/861c6917-8c93-4f0c-9cd6-e8a73cb0c541

> FDA 483 for Asahi Intecc Usa Inc on June 01, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Asahi Intecc Usa Inc
- Inspection Date: 2023-06-01
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Asahi Intecc Usa Inc. in Tustin, CA, was inspected from May 30 to June 1, 2023, and received a Form FDA 483 with two observations. The inspection revealed deficiencies in establishing adequate procedures for design validation, specifically regarding sterilization validation for Crosswalk devices, and for receiving, reviewing, and evaluating product complaints. These issues indicate a need for improved quality system controls.

## Related Officers

- [Kevin N. Tran](https://www.keypedia.com/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.keypedia.com/companies/asahi-intecc-usa-inc/62d9e9d8-6d0d-4162-aa71-9ea5bb630c55

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