# FDA 483 - True Function Laboratory, Inc. - August 07, 2023

Source: https://www.keypedia.com/records/483/true-function-laboratory-inc/78e0c163-5191-4a42-8e58-7918955bcb62

> FDA 483 for True Function Laboratory, Inc. on August 07, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: True Function Laboratory, Inc.
- Inspection Date: 2023-08-07
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: True Function Laboratory, Inc. in La Mesa, CA, a manufacturer of anti-snoring and anti-sleep apnea devices, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate procedures and documentation for complaint handling, equipment control, nonconforming materials, device history records, acceptance activities, corrective and preventive actions, and management review. Several observations were repeats, indicating a systemic lack of compliance with established procedures and regulatory requirements.

## Related Documents

- [483 - 2023-08-07](https://www.keypedia.com/records/483/true-function-laboratory-inc/3a80e0fc-bb36-42e9-a0ea-802c770d46f4)

## Related Officers

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

Company: https://www.keypedia.com/companies/true-function-laboratory-inc/af73cf70-da7f-4112-9543-a6751201242d

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