Honest Globe, Inc. – FDA 483, Oct 8, 2019

Norquest Globe, Inc., an OTC drug manufacturer in Santa Ana, CA, was cited for significant deficiencies across its quality system, laboratory controls, facilities, equipment, and packaging/labeling. Key issues include an inadequate Quality Control Unit, lack of annual product reviews, absence of a change control program, and failure to investigate out-of-specification results. The firm also lacked validated stability programs, consistent microbiological testing, validated cleaning procedures, and proper equipment qualification.