# FDA 483 - Pacon Manufacturing Corporation - June 20, 2017

Source: https://www.keypedia.com/records/483/pacon-manufacturing-corporation/38d74f17-ca8a-4b8c-aaa0-1821d4a1f10f

> FDA 483 for Pacon Manufacturing Corporation on June 20, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pacon Manufacturing Corporation
- Inspection Date: 2017-06-20
- Product Type: device
- Office Name: New Jersey District Office
- Summary: The FDA issued a Form 483 to Pacon Manufacturing Corporation, a medical device firm in Somerset, NJ, following an inspection. The observations primarily concern deficiencies in maintaining device master records and device history records, as well as a lack of formal agreements with suppliers regarding product changes. These issues indicate a need for improved quality system controls for medical device manufacturing.

## Related Documents

- [483 - 2020-03-13](https://www.keypedia.com/records/483/pacon-manufacturing-corporation/5f567f2d-25f3-4c51-80c6-cf2ef4dcea3a)

## Related Officers

- [Esteban Beltran](https://www.keypedia.com/people/esteban-beltran/9a9bf6b2-ecdf-494c-82f4-5ef5932d629a)

Company: https://www.keypedia.com/companies/pacon-manufacturing-corporation/ac269569-d212-4880-84eb-ab3fc9e40c67

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