FDA 483 - Emballages Spectrum Inc. - November 06, 2025

An FDA inspection of Spectrum Packaging Inc., a drug packager and labeler in Montreal, revealed three significant observations. The firm was cited for failing to adequately qualify packaging equipment, lacking established written procedures for production and process controls, and not demonstrating appropriate cleaning methods for equipment. These issues indicate deficiencies in ensuring drug product quality and compliance with cGMP regulations.