# FDA 483 - Clinicon Corp - April 19, 2026

Source: https://www.globalkeysolutions.net/records/483/clinicon-corp/71153e56-76f9-4816-ae29-e15e0f2c9fc5

> FDA 483 for Clinicon Corp on April 19, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Clinicon Corp
- Inspection Date: 2026-04-19
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of Clinicon Corp, a Class II Medical Device Manufacturer in Oceanside, CA, revealed significant deficiencies in their quality system. The firm failed to adequately validate processes, document equipment calibration and maintenance, and maintain proper records for supplier evaluations, incoming product acceptance, and device history. Additionally, Clinicon Corp did not submit required annual reports for their Class IV laser product.

## Related Documents

- [WARNING_LETTER - 2019-04-04](https://www.globalkeysolutions.net/records/warning_letter/clinicon-corp/fcbe73b1-ecc6-4810-b7ff-6730b0a31010)

## Related Officers

- [Cso](https://www.globalkeysolutions.net/people/daniel-j-lahar/d4e329c0-b6a5-42ca-acde-b79413b245ea)

Company: https://www.globalkeysolutions.net/companies/clinicon-corp/a1b2ed05-f11e-4b95-93c6-19d390430887

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face