# FDA 483 - Pausch LLC - March 23, 2026

Source: https://www.keypedia.com/records/483/pausch-llc/2de25853-93e8-4035-89ef-d6aa76ff4bbd

> FDA 483 for Pausch LLC on March 23, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pausch LLC
- Inspection Date: 2026-03-23
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Pausch LLC, a medical device manufacturer in Tinton Falls, NJ, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant deficiencies in the firm's quality management system, including a lack of documented risk analysis, inadequate corrective actions, and insufficient supplier and management review processes. These issues indicate a systemic failure to adhere to established quality procedures for medical device manufacturing.

## Related Documents

- [483 - 2022-11-09](https://www.keypedia.com/records/483/pausch-llc/1fc1d56e-98c7-45cf-a400-57016fd38eb9)

## Related Officers

- [William R. Chang](https://www.keypedia.com/people/william-r-chang/67893bac-29e2-45b4-ba2c-1ef548781b9c)

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