# FDA 483 - Hearing Lab Technology, LLC - April 20, 2023

Source: https://www.globalkeysolutions.net/records/483/hearing-lab-technology-llc/89079eba-3b02-4b78-a264-5100f6044f59

> FDA 483 for Hearing Lab Technology, LLC on April 20, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hearing Lab Technology, LLC
- Inspection Date: 2023-04-20
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Hearing Lab Technology, LLC in Bristol, PA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to establish procedures for finished device acceptance, specifically for wireless functionality testing of their in-the-ear wireless hearing aids. Additionally, device history records lacked proper documentation and signatures for manufacturing and quality control steps.

## Related Officers

- [Investigations](https://www.globalkeysolutions.net/people/edward-d-mcdonald/69224613-2b96-426a-99dd-e1cfe5ff1713)

Company: https://www.globalkeysolutions.net/companies/hearing-lab-technology-llc/b8e5351f-fc49-49c5-9d4c-d370d5c691d2

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8