FDA 483 - Meenaxi Enterprise Inc. - September 18, 2024

Meenaxi Enterprise Inc. in Edison, NJ, was cited with three observations during an FDA inspection of its Foreign Supplier Verification Program (FSVP). The firm failed to develop an FSVP for some imported foods, a repeat observation, and its existing FSVP did not adequately assure foreign supplier compliance regarding hazard evaluation and sterilization validation for imported spices. Additionally, the company lacked adequate written procedures for foreign supplier verification activities, specifically regarding the necessity of onsite audits for high-risk foods.