Accupac, LlcFebruary 13, 2026

FDA 483 - Accupac, Llc - February 13, 2026

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Record Details

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.

Company: Accupac, Llc
Inspection Date: February 13, 2026
Product Type: Other
Office: New Jersey District Office
Person: Frank J. Marciniak

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ID · 1ea3950d-8642-4dbd-b118-9a393c6c205c