# FDA 483 - Audicon Corporation - August 08, 2025

Source: https://www.globalkeysolutions.net/records/483/audicon-corporation/967559a9-d2f5-48c9-b2ff-04f8e536827e

> FDA 483 for Audicon Corporation on August 08, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Audicon Corporation
- Inspection Date: 2025-08-08
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: Audicon, a specification developer and complaint handling establishment in Ontario, CA, was cited for significant deficiencies in its quality system. The inspection revealed a lack of established procedures for corrective and preventive actions, inadequate complaint handling processes, and missing written procedures for Medical Device Reporting (MDRs). Additionally, the firm failed to establish procedures for employee training and identifying training needs.

## Related Officers

- [Marlo-Ian M. Alintanahin](https://www.globalkeysolutions.net/people/marlo-ian-m-alintanahin/a37da927-b369-4753-b275-41743556f25e)

Company: https://www.globalkeysolutions.net/companies/audicon-corporation/0bbd5f6c-7553-428a-985a-7a11cac780cf

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