# FDA 483 - Accupac, Llc - February 13, 2026

Source: https://www.keypedia.com/records/483/accupac-llc/1ea3950d-8642-4dbd-b118-9a393c6c205c

> FDA 483 for Accupac, Llc on February 13, 2026. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Accupac, Llc
- Inspection Date: 2026-02-13
- Product Type: other
- Office Name: New Jersey District Office
- Summary: Accupac, Llc in Lakewood, NJ was inspected and cited for four observations related to its manufacturing and quality systems. The inspection revealed deficiencies in process validation, UDI submission to GUDID, risk management application, and supplier performance monitoring. These issues indicate a need for improved adherence to quality control procedures and regulatory requirements.

## Related Documents

- [EIR - 2019-03-19](https://www.keypedia.com/records/eir/accupac-llc/b9568c42-c81d-45fc-b785-24c0e62f9eb3)
- [483 - 2021-11-18](https://www.keypedia.com/records/483/accupac-llc/8d9e6eb8-0d74-4945-8860-fa0e5c35d734)

## Related Officers

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

Company: https://www.keypedia.com/companies/accupac-llc/f9c2fbfc-4f22-433c-8e1c-bde11182952f

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