# FDA 483 - Precision Forms, Inc. - May 01, 2025

Source: https://www.keypedia.com/records/483/precision-forms-inc/d54781ca-48b8-4458-9685-6e7be04e02e3

> FDA 483 for Precision Forms, Inc. on May 01, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Precision Forms, Inc.
- Inspection Date: 2025-05-01
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Precision Forms, Inc. in Butler, NJ, a manufacturer of medical devices, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for monitoring and controlling validated cleaning processes, properly validate processes under worst-case conditions, and implement effective corrective and preventive actions through robust quality data analysis. These issues indicate a lack of control over critical manufacturing processes and quality management.

## Related Officers

- [Jonathan Ho](https://www.keypedia.com/people/jonathan-ho/434f1c30-b660-4bc9-bc31-017366282edd)

Company: https://www.keypedia.com/companies/precision-forms-inc/299e70b7-4df5-409a-82a7-c2142b9686c3

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