# FDA 483 - CLER VISION INC - February 20, 2025

Source: https://www.globalkeysolutions.net/records/483/cler-vision-inc/b9331619-90fb-4c80-a0bd-1439fa11a6c4

> FDA 483 for CLER VISION INC on February 20, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CLER VISION INC
- Inspection Date: 2025-02-20
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: CLER VISION INC, a contract manufacturer of rigid contact lenses in Riverside, CA, received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in process validation documentation, corrective and preventive action procedures, complaint handling, and supplier approval processes. These issues included a server breach that impacted quality records and a failure to follow established procedures for various quality system elements.

## Related Officers

- [Linda Galindo](https://www.globalkeysolutions.net/people/linda-galindo/6bc29df6-192b-4d89-92ae-20cc1660d9ad)

Company: https://www.globalkeysolutions.net/companies/cler-vision-inc/5f2af707-653f-4aec-9f0e-4a356b5a695d

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b