# FDA 483 - Arklign Laboratories, Inc. - October 28, 2025

Source: https://www.keypedia.com/records/483/arklign-laboratories-inc/f337100d-4c7c-40fe-8f00-c615fa2b607c

> FDA 483 for Arklign Laboratories, Inc. on October 28, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arklign Laboratories, Inc.
- Inspection Date: 2025-10-28
- Product Type: device
- Office Name: San Francisco District Office
- Summary: Arklign Laboratories, Inc., a repackager/relabeler of dental restorations in San Jose, CA, was cited for significant deficiencies across its quality system. The inspection revealed a lack of established procedures for critical processes like CAPA, complaint handling, MDR, quality plans, and audits, alongside failures in UDI labeling and database registration. These findings indicate a fundamental absence of a compliant quality management system.

## Related Officers

- [Natasha R. Johnson](https://www.keypedia.com/people/natasha-r-johnson/ae9e5ea3-74dd-427e-9f8b-32faa975679e)

Company: https://www.keypedia.com/companies/arklign-laboratories-inc/6493d494-d76c-4ddd-a42c-268921209d3d

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df