# FDA 483 - Zerigo Health, Inc - August 19, 2019

Source: https://www.keypedia.com/records/483/zerigo-health-inc/365a894f-f142-4f33-a27a-f11fd949a8ee

> FDA 483 for Zerigo Health, Inc on August 19, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zerigo Health, Inc
- Inspection Date: 2019-08-19
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: CLARIFY MEDICAL INC, a medical device manufacturer in San Diego, CA, was inspected by the FDA. The inspection revealed that the firm's procedures for design change were not adequately established. Specifically, the design control procedure failed to outline how design changes are identified, documented, reviewed, validated, or verified, as demonstrated by an un-updated design specification for the Clarify Phototherapy System.

## Related Officers

- [Juanj Wu](https://www.keypedia.com/people/juanj-wu/0d3e8970-b524-49f6-a307-079091b3c91d)

Company: https://www.keypedia.com/companies/zerigo-health-inc/be93f343-327d-40ac-8461-fcc21bff3250

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