FDA 483 - VitaCare Labs Inc. - May 16, 2025

VitaCare Labs Inc., an OTC drug manufacturer in Mississauga, was inspected by the FDA and received a Form 483 with six observations, many of which were repeats from a previous inspection in 2018. The inspection revealed significant deficiencies across production, quality, and laboratory control systems, including inadequate process and cleaning validations, poor equipment maintenance, incomplete batch records, failure to follow stability testing programs, insufficient component testing, and inadequate investigations into microbial contamination. These issues indicate a systemic failure to ensure drug product quality, purity, and strength.