DSM Nutritional Products, Inc. – FDA EIR, Nov 28, 2022

An FDA remote inspection of DSM Nutritional Products, Inc. in Parsippany, NJ, was conducted from November 15 to November 28, 2022. The inspection focused on the company's Foreign Supplier Verification Program (FSVP) for imported finished dietary supplements, under the regulatory framework of 21 CFR 1.511(c). While the inspection concluded that DSM maintained records satisfying the FSVP regulations, audits of their foreign suppliers revealed several critical issues. One supplier, (b) (4), responsible for Melatonin Gummies, had three major non-compliance findings: insufficient food safety training for teams, deficiencies in their food defense plan, and improper storage conditions for in-process materials. Corrective and Preventive Action (CAPA) plans were required from this manufacturer for approval by DSM's third-party certifying body. Another supplier, (b) (4), producing fish oil, initially had a foundation crack noted but resolved it. However, their packaging site, (b) (4), faced multiple major non-compliance issues, including inadequate GMP area separation, pest control deficiencies, and issues with cGMP segregation controls and air handling practices. These issues have since been addressed with an approved CAPA report. The FDA recommended that DSM ensure customs brokers provide more detailed shipment descriptions, maintain organized and current FSVP records, proactively monitor foreign suppliers against FDA Import Alerts, and consider additional FSVP training for their team. Failure to comply with FSVP regulations can lead to warning letters and potential import restrictions.