FDA 483 - Kari Gran Inc. - July 08, 2022

Kari Gran Inc. in Seattle, WA, was inspected by the FDA, resulting in 11 observations related to significant deficiencies in their manufacturing and quality control processes for drug products, specifically Essential SPF. The inspection revealed a lack of adequate finished product testing, insufficient investigations into product complaints, and absent or inadequate written procedures for quality control, production, process validation, annual product reviews, and stability testing. Additionally, issues were noted with batch record documentation, component testing, and product labeling.