# FDA 483 - Freudenberg Medical, LLC - September 19, 2016

Source: https://www.keypedia.com/records/483/freudenberg-medical-llc/0a2e6f55-bfcd-46ce-b3e3-034cb63c5336

> FDA 483 for Freudenberg Medical, LLC on September 19, 2016. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Freudenberg Medical, LLC
- Inspection Date: 2016-09-19
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Freudenberg Medical, LLC, a medical device contract manufacturer in Baldwin Park, CA, was inspected by the FDA. The inspection revealed a significant quality system deficiency related to the lack of validation for a critical manufacturing process for a medical device, which could impact product quality and safety.

## Related Officers

- [Investigator](https://www.keypedia.com/people/janet-pulver/d46b01cd-8c3d-4a54-bb91-843e0f94de89)

Company: https://www.keypedia.com/companies/freudenberg-medical-llc/13ae2343-6a53-4212-8d4d-6f1397ac094f

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