Innovation Specialties, Inc. – FDA 483, Dec 8, 2023

An FDA inspection of Innovation Specialties, Inc. in Culver City, CA, an own label distributor, revealed significant deficiencies in its quality control unit. The firm failed to adequately follow responsibilities and procedures, including insufficient GMP training, non-customized SOPs, lack of QCU approval for controlled documents, and inadequate procedures for equipment maintenance and incoming product testing. These issues indicate a failure to ensure drug products meet applicable good manufacturing practices.