FDA 483 - Vita-Herb Nutriceuticals Inc - September 19, 2022

Vit-Herb Nutraceuticals, Inc. in Placentia, CA, an OTC drug manufacturer, was cited with five observations during an FDA inspection. The firm demonstrated significant deficiencies in its quality control unit, including inadequate investigations into out-of-specification results, a lack of written procedures for critical processes like change control and supplier qualification, and incomplete laboratory records. Additionally, the firm failed to properly monitor its water system and adhere to its stability testing program for veterinary drugs, indicating systemic issues with quality oversight and data integrity.