Blaine Labs Inc – FDA 483, Dec 22, 2025
An FDA inspection of Blaine Labs Inc. in Santa Fe Springs, CA, a drug manufacturer, revealed widespread deficiencies across its quality, laboratory, production, facilities, and materials systems. The firm failed to follow established procedures, conduct thorough investigations, ensure data integrity, and validate critical processes and equipment. These issues indicate a significant lack of adherence to current Good Manufacturing Practices, posing risks to drug product quality and patient safety.
ID · 6233edca-c2e5-4389-8ac0-43037dd01b10
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.