FDA EIR - Penta International Corp - February 10, 2022

An FDA limited Preventive Controls in Human Foods inspection of Penta International Corp, located in Livingston, NJ, was conducted on February 10, 2022. This surveillance inspection, operating under Compliance Program 7303.015, focused on the company's role as a warehouse and repacker of raw material ingredients for flavors, fragrances, and pharmaceuticals. The objective was to evaluate sanitation conditions and overall product protection in its warehousing and repacking areas.

The inspection concluded without identifying any deficiencies. Specifically, no issues were found regarding direct product contamination, product temperature control, equipment storage, employee work practices, building maintenance, waste management, or pest control. A thorough review of the firm's food safety plan and employee training records also revealed no non-compliance with Current Good Manufacturing Practices (CGMP) or the regulatory framework of Preventive Controls for Human Foods.

As a result of these findings, no FDA-483 Inspectional Observations were issued to Penta International Corp. The absence of observed violations meant that no specific corrective actions were required from the company following this inspection.