# FDA 483 - Chamberlain Technologies LLC - May 09, 2025

Source: https://www.globalkeysolutions.net/records/483/chamberlain-technologies-llc/af82db1e-7475-4f11-8787-831d37ac23fb

> FDA 483 for Chamberlain Technologies LLC on May 09, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chamberlain Technologies LLC
- Inspection Date: 2025-05-09
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Chamberlain Technologies LLC in Deer Park, IL, revealed that the firm failed to report a correction or removal of Class 2 medical devices to the FDA. The company incorrectly classified the action as a stock recovery, even though affected devices had been distributed and one was implanted in a patient, and its risk assessment for not reporting was inconsistent.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/chamberlain-technologies-llc/bd9e0488-4ea3-439f-9bca-0e931271790e

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669