# FDA 483 - American Laser Healthcare Corp - July 17, 2019

Source: https://www.globalkeysolutions.net/records/483/american-laser-healthcare-corp/828999c1-5a67-48cc-be3f-14093f3983b0

> FDA 483 for American Laser Healthcare Corp on July 17, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: American Laser Healthcare Corp
- Inspection Date: 2019-07-17
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: American Laser Healthcare Corp, a medical device manufacturer in Irvine, CA, received one observation during an FDA inspection. The firm failed to perform software validation for the software used to operate their infrared pad device. This indicates a deficiency in their quality system regarding device software control.

## Related Officers

- [Matthew D. Schnittker](https://www.globalkeysolutions.net/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.globalkeysolutions.net/companies/american-laser-healthcare-corp/8e152eca-84a2-4ee3-a649-4470ea3b5a72

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