# FDA 483 - Meta Dental - June 30, 2022

Source: https://www.keypedia.com/records/483/meta-dental/4854ca63-0d22-4232-bb37-9f3ef9e2147d

> FDA 483 for Meta Dental on June 30, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Meta Dental
- Inspection Date: 2022-06-30
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Meta Dental in Northridge, CA, conducted from June 29-30, 2022, identified a significant procedural deficiency. The firm failed to establish written procedures for critical steps in the manufacture of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), specifically regarding the receipt, storage, shipment, and distribution of human bone products. This lack of procedures led to the distribution of products without proper controls.

## Related Officers

- [Celeta S. Coves](https://www.keypedia.com/people/celeta-s-coves/d0f63577-a6e4-4872-b06c-a024188a04ba)

Company: https://www.keypedia.com/companies/meta-dental/fbf37001-943f-4eb7-9ca3-33dd42f27b58

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