FDA 483 - GUERBET LLC - August 28, 2025

An FDA Form 483 was issued to an unnamed firm, addressed to Ahmed Y. Abdelal, Pharm. D., Head of Medical and Regulatory Affairs, North America, following an inspection conducted from August 25 to August 28, 2025, in Parsippany, NJ. The primary observation detailed a significant deficiency in postmarketing safety reporting practices. The firm failed to include copies of published scientific articles with global literature-based, postmarketing expedited 15-day Alert reports. Specifically, during the review of nine products, investigators found that 12 out of 12 such 15-day alert reports did not contain the required accompanying published articles. This indicates a systemic issue in submitting complete postmarketing adverse event reports, which are crucial for the FDA's oversight of product safety. This non-compliance falls under the regulatory framework for drug safety reporting, where firms are obligated to provide comprehensive information for all expedited reports. The observation highlights a need for the firm to review and enhance its procedures for collecting, processing, and submitting postmarketing safety data to ensure full compliance with federal regulations. Corrective actions are expected to address these deficiencies to uphold regulatory standards.