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Talk to a SpecialistTalk to a SpecialistKari Gran Inc., a drug manufacturer, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter SPF sunscreen products. The company failed to perform adequate release testing for multiple batches prior to distribution, including insufficient testing of zinc oxide as the active ingredient, and released batches to the market before receiving test results. Additionally, the firm did not establish appropriate stability testing programs or written protocols to determine proper storage conditions and expiration dates, and did not conduct routine finished product testing on subsequent batches after initial production.