FDA 483 - Ethical Products Inc. - July 31, 2025

Ethical Products Inc. in Bloomfield, NJ, received a Form 483 citing significant deficiencies in its Foreign Supplier Verification Program (FSVP) during an inspection. The firm failed to adequately identify hazards like Thyroid Hormone in imported products, conduct required supplier verification activities including audits, and maintain proper documentation, including English translations of critical records. These issues indicate a moderate level of non-compliance with regulations governing imported food safety.