FDA 483 - Resonance Laboratories Private Limited - February 07, 2025

An FDA inspection of Resonance Laboratories Private Limited in Bengaluru, India, an API manufacturer, revealed significant deficiencies across multiple areas. Observations included inadequate cleaning and sanitization procedures, incomplete batch production records, and insufficient process validation. Additionally, the firm was cited for unvalidated analytical methods, deficient drug substance specifications, and a lack of appropriate personnel training.