FDA 483 - Honest Globe, Inc. - October 08, 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.