# FDA 483 - Optical Connection LLC - January 16, 2020

Source: https://www.globalkeysolutions.net/records/483/optical-connection-llc/6169565e-d7fe-4faf-82e0-d34290c101e6

> FDA 483 for Optical Connection LLC on January 16, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Optical Connection LLC
- Inspection Date: 2020-01-16
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: This FDA Form 483 was issued to Optical Connection LLC, an initial importer/distributor of class II contact lenses in San Diego, CA, following an inspection from January 8-16, 2020. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for complaint handling, CAPA, acceptance activities, nonconforming product control, document control, and a complete lack of documented personnel training. The firm's President acknowledged that several procedures were either not established or not followed.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/optical-connection-llc/4ff8a379-5ac8-4497-b0ff-18efbf519370

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