# FDA 483 - Phillips Precision, Inc. - July 17, 2024

Source: https://www.keypedia.com/records/483/phillips-precision-inc/3f15c660-de8e-4fca-90c3-136e7cdbeafa

> FDA 483 for Phillips Precision, Inc. on July 17, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Phillips Precision, Inc.
- Inspection Date: 2024-07-17
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Phillips Precision, Inc. received a Form 483 citing significant deficiencies in its quality system, particularly concerning process validation for cleaning implantable devices and surgical instruments. The firm failed to adequately validate cleaning processes, monitor critical process parameters, and establish effective corrective and preventive actions. Additionally, issues were noted in the control of nonconforming product, acceptance activities, equipment maintenance, contamination prevention, and employee training.

## Related Documents

- [WARNING_LETTER - 2024-07-17](https://www.keypedia.com/records/warning_letter/phillips-precision-inc/eab0bf23-1243-4b22-a1ed-4283d12ee98d)

## Related Officers

- [Jonathan Ho](https://www.keypedia.com/people/jonathan-ho/434f1c30-b660-4bc9-bc31-017366282edd)
- [Nakesh N. Gomanie](https://www.keypedia.com/people/nakesh-n-gomanie/cfffa8e1-fdfb-4bc4-a845-44bcd593c9c7)

Company: https://www.keypedia.com/companies/phillips-precision-inc/76202fe1-2821-4f40-9569-3e911cad72ba

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