FDA 483 - Flamma USA LLC - October 24, 2025

During an inspection conducted by the Food and Drug Administration's Philadelphia District Office from October 20 to October 24, 2025, a firm received an FDA Form 483 outlining two significant observations related to its manufacturing processes. The first observation noted the firm's failure to complete Performance Qualification (PQ) for critical equipment, specifically a reactor, prior to initiating process validation. The inspection found that the company proceeded directly from Operational Qualification to process validation without documented evidence that the equipment consistently operates within established parameters under actual production conditions. The second observation highlighted an absence of adequate scientific rationale for selecting swabbing locations in cleaning verification protocols. The firm's protocol for equipment cleaning lacked documented justification for sampling points and did not demonstrate consideration of critical factors such as difficult-to-clean areas, complex product contact surfaces, or locations prone to residue accumulation. The company acknowledged that these sampling locations were arbitrarily chosen without a proper risk assessment or engineering evaluation. These observations indicate deviations from good manufacturing practices, necessitating prompt attention and corrective actions from the firm to ensure product quality and regulatory compliance.