Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistYichang Jiayuan Foodstuffs Co., Ltd was cited for manufacturing ready-to-eat Mandarin Oranges in light syrup in glass jars under insanitary conditions that could have resulted in contamination with filth or posed health risks. The facility violated Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls requirements under 21 CFR Part 117, with FDA investigators documenting serious deviations during their September 2022 inspection. The products were determined to be adulterated under the Federal Food, Drug, and Cosmetic Act because of inadequate sanitary controls during preparation, packing, and holding. The company submitted corrective actions and supporting documentation in October 2022, including revised procedures, training records, and calibration records for FDA review.