# FDA 483 - APEX DENTAL SLEEP LAB LLC - February 22, 2024

Source: https://www.keypedia.com/records/483/apex-dental-sleep-lab-llc/d65483dc-f3a0-44b5-8fdb-5761ba376898

> FDA 483 for APEX DENTAL SLEEP LAB LLC on February 22, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: APEX DENTAL SLEEP LAB LLC
- Inspection Date: 2024-02-22
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of APEX DENTAL SLEEP LAB LLC in La Mesa, CA, a manufacturer of dental sleep devices, revealed significant deficiencies in its quality system. Observations included inadequate documentation of corrective and preventive actions, lack of procedures for rework of nonconforming products, and insufficient complaint handling processes. Additionally, the firm failed to include Unique Device Identifiers (UDI) on its finished medical device labels.

## Related Officers

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

Company: https://www.keypedia.com/companies/apex-dental-sleep-lab-llc/96c2b395-02e6-4a8e-8662-5299c7a1fac8

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