FDA 483 - Oak Ridge Products - September 30, 2022

Oak Ridge Products, a medical device manufacturer in McHenry, IL, was inspected by the FDA and received a Form 483 with eight observations. The inspection revealed significant deficiencies across multiple quality system areas, including design control, CAPA, MDR procedures, complaint handling, incoming product acceptance, management reviews, quality audits, and personnel training. These issues indicate a broad lack of adherence to established quality system requirements.