# FDA 483 - Pausch LLC - November 09, 2022

Source: https://www.keypedia.com/records/483/pausch-llc/1fc1d56e-98c7-45cf-a400-57016fd38eb9

> FDA 483 for Pausch LLC on November 09, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pausch LLC
- Inspection Date: 2022-11-09
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Pausch LLC, a medical device manufacturer in Tinton Falls, NJ, was cited with six observations during an FDA inspection. The inspection revealed significant deficiencies across its quality system, including inadequate maintenance of device master and history records, and failures in establishing proper procedures for corrective and preventive actions, complaint handling, nonconforming product control, and employee training. These issues indicate a broad lack of adherence to quality system regulations for medical devices.

## Related Officers

- [Frank J. Marciniak](https://www.keypedia.com/people/frank-j-marciniak/6995351a-6afc-4056-9692-d4aeb711dd92)

Company: https://www.keypedia.com/companies/pausch-llc/9326648d-7ca4-49a0-b5de-a8c5aa04f9ce

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248